Impact of an Evolving Regulatory Landscape on Skin Cancer Drug Development in the U.S

Publication
Preprint
Article and Authorship Details

Article type: This is a pre-print. This article is under review.

Authors: David M. Miller1* MD PhD, Sophia Z. Shalhout1 PhD, Denise Casey3 MD, Lola Fashoyin-Aje2 MD, Steven Lemery2 MD, Marc R. Theoret2 MD, Richard Pazdur2 MD

1Department of Medicine, Division of Hematology/Oncology and the Department of Dermatology, Massachusetts General Hospital, Boston, MA 2The Food and Drug Administration, Silver Spring, Maryland. 3DataRevive LLC, Rockville, MD 20850

*Corresponding author: David M. Miller MD PhD
Massachusetts General Hospital
Email:

Funding sources: None

Conflicts of interest: David M. Miller has received honoraria for work on advisory boards for Pfizer Inc., Merck Sharpe & Dohme, Sanofi Genzyme, Regeneron, EMD Serono, and Checkpoint Therapeutics. This article reflects the views of the authors and should not be construed to represent the views or policies of the FDA.

Manuscript word count: 2493
Abstract word count: 149
References: 12
Figures: 8
Tables: 2

Keywords: regulatory medicine, cutaneous oncology, melanoma, Merkel cell carcinoma, squamous cell carcinoma

Abbreviations: 2D Measurement: Sum of two dimensional tumor measurements, ACTG: AIDS Clinical Trials Group Oncology Committee of the National Institute of Allergy and Infectious Diseases criteria, AK: actinic keratosis, BCC: basal cell carcinoma, CCR: complete clearance rate, CTCL: cutaneous T-cell lymphoma, DESI: Drug Efficacy Study Implementation, DFSP: dermatofibrosarcoma protuberans, FDA: US Food and Drug administration, FDAAA: Food and Drug Administration Amendments Act, FDAMA: Food and Drug Administration Modernization Act, FDARA: Food and Drug Administration Reauthorization Act, FDASIA: Food and Drug Administration Safety and Innovation Act, GRS: global response criteria, HDAC: histone deacetylase, KS: Kaposi’s sarcoma, laBCC: locally advanced basal cell carcinoma, laCSCC: locally advanced cutaneous squamous cell carcinoma, lb95%CI: lower bound 95% confidence interval, mBCC: metastatic basal cell carcinoma, MANUF (CMC): Chemistry, Manufacturing and Controls, MCC: Merkel cell carcinoma, mCSCC: metastatic cutaneous squamous cell carcinoma, mRECIST: modified RECIST, mSWAT: modified SWAT, ORR: overall response rate, OS: overall survival, PFS: progression-free survival, PHBPA: Public Health and Bioterrorism Preparedness Act, PK: pharmacokinetic analysis, RECIST: Response Evaluation Criteria in Solid Tumors, r/mCSCC: recurrent or metastatic cutaneous squamous cell carcinoma, rCTCL: refractory cutaneous T-cell lymphoma, RFS: relapse-free survival, SCC: squamous cell carcinoma, SWAT: severity-weighted assessment tool, u/mMelanoma: unresectable or metastatic melanoma, U.S.: United States, WHO: world health organization; WSSI: weighted skin severity index.

ABSTRACT

Background: There has been a rapid proliferation of FDA-approved medications with labeled indications for skin cancer over the last decade, with particular growth over the last 5 years.
Objective: We aimed to evaluate the impact of an evolving U.S. regulatory framework on drug development programs to better understand current trends and regulatory considerations when adjudicating drug approvals for patients with skin cancer.
Methods: We reviewed publicly-available regulatory documents of all systemic medications with a labeled indication for skin cancer.
Results: We identified 130 FDA approvals that resulted in a unique indication, usage, formulation or dosage change in skin cancer since 1949.
Limitations: Publicly available data from the mid-to-late 20th century is limited.
Conclusions: The therapeutic landscape in skin cancer has changed greatly since the first approval in 1949. In concert, regulatory medicine has also evolved over the last 70 years with the aim of ensuring safe and effective medicines for a diverse array of patients.

INTRODUCTION

Skin cancer is a heterogeneous group of malignancies that result from neoplasia of keratinocytes, melanocytes, adnexal structures, nervous tissue, stromal cells and effectors of the innate and adaptive immune system. In aggregate, new cases of skin cancer outnumber all other forms of cancer combined, with keratinocyte carcinoma alone accounting for 3-4 million cases in the US every year1. In keeping with the diverse mechanisms that give rise to cutaneous malignancy, there are a heterogeneous group of drug therapies used to treat skin cancer, which includes cytotoxic agents, targeted therapies, and immunotherapies (Table 1). Analogous to the changing therapeutic landscape in cutaneous oncology, the field of regulatory medicine has also evolved substantially over the last century.

To understand how current trends and regulatory approaches to adjudicating drug approvals for skin cancer are influenced, it is useful to also recognize the evolution of regulatory medicine in general. For example, the FDA’s modern regulatory function commenced with the Pure Food and Drugs Act of 1906, which prohibited the manufacturing and distribution of misbranded products. Galvanized in large part by the Elixir of Sulfanilamide disaster, Congress passed the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. The FD&C Act contained provisions requiring new drugs to be shown safe before marketing. In 1962, the FD&C statute was amended to require proof of efficacy in addition to safety prior to granting marketing approval (Figure 1).

Figure 1. Landscape of Regulatory Medicine and Cutaneous Oncology

Click Here for Figure 1

Figure 1. Landscape of Regulatory Medicine and Cutaneous Oncology
Key landmark acts responsible for shaping and influencing trends in regulatory medicine are overlaid among the FDA Approvals specific to cutaneous oncology. Briefly, the Pure Food and Drugs Act of 1906 prohibited “the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs or medicines, and liquors”2. In 1937, more than 100 people died secondary to ingestion of diethylene glycol contained in the Elixir Sulfanilamide3. Subsequently, Congress passed the Federal Food, Drug, and Cosmetic Act (FD&C) in 1938, which required new drugs to be safe prior to marketing. In 1962, Congress passed amendments to the FD&C, commonly known as the Kefauver-Harris Amendments, which required that sponsors demonstrate scientific evidence of the effect of the purported labeling claim, not just safety. The statutory requirement remains that to obtain marketing approval, sponsors must provide substantial evidence of the drug’s safety and effectiveness for its intended use. Responding to complaints about delays in drug approvals, Congress passed the Prescription Drug User Fee Act (PDUFA) in 1992, which permitted the FDA to collect fees from sponsors in order to provide more efficient and timely reviews of new drug and biologic applications. PDFUA must be reauthorized every five years. It was renewed in 1997 with FDAMA (Food and Drug Administration Modernization Act), 2002 as part of the Public Health and Bioterrorism Preparedness Act (PHBPA), 2007 as FDAAA (Food and Drug Administration Amendments Act), 2012 with FDASIA (Food and Drug Administration Safety and Innovation Act) and in 2017 as part of FDARA (Food and Drug Administration Reauthorization Act). Each reauthorization incorporates initiative and programs to continue optimizing the regulatory role of the FDA. The 21st Century Cures Act was passed by the 114th Congress with the goal to accelerate the discovery and development of new therapies. Subtitle C, section 3022 called for a program to evaluate the potential use of real world evidence to help support regulatory decisions. Abbreviations - FDAAA: Food and Drug Administration Amendments Act; FDAMA: Food and Drug Administration Modernization Act; FDARA: Food and Drug Administration Reauthorization Act; FDASIA: Food and Drug Administration Safety and Innovation Act; PHBPA: Public Health and Bioterrorism Preparedness Act.



In this article, we report an examination of the totality of drug approvals for skin cancer with a specific focus on the evolving regulatory landscape as it pertains to the assessment of clinical benefit. We highlight changes in regulatory considerations regarding trial design, efficacy endpoints, and the overall benefit:risk assessment as they relate to labeling claims for use in patients with skin cancer. Knowledge of the regulatory framework allows physicians, investigators, industry and regulators to promote continued innovation in the regulatory sciences and, consequently, increases efficiency in development of safe and effective medications.

METHODS

Overview
To evaluate the evidence used to support labeled claims in skin cancer we reviewed FDA New Drug Application (NDA) or Biological License Application (BLA) reviews, and the US product labels, that are indexed on the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) from 1949 to February 09, 2021.

Data
In addition to the product labels and NDA and BLA reviews, data were also obtained from OpenFDA (https://download.open.fda.gov/drug/drugsfda/drug-drugsfda-0001-of-0001.json.zip).

Disease Selection
We chose the following eight skin neoplasia: actinic keratosis, basal cell carcinoma, cutaneous T-cell lymphoma, dermatofibrosarcoma protuberans, kaposi’s sarcoma, melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma. These were selected for our analysis because each category has at least one FDA-approved therapy. Actinic keratosis, although not an overt malignancy, but rather a pre-malignant condition, was included because of its importance in the management of skin cancer and ubiquitous presence in dermatological practice. In general, drugs for actinic keratosis and local treatments for BCC and SCC are reviewed outside of the oncology review Divisions within the FDA.

Therapeutic Inclusion Criteria
Therapies that have a labeled indication for skin neoplasia (as defined above) were selected. Only labeling modifications of NDAs or BLAs were selected. If a molecular entity had an abbreviated new drug application (ANDA) associated - e.g., a generic form of the therapy was approved), the ANDA was not included in the analysis, as these generally not required to include clinical data to establish safety and efficacy.

Endpoint Selection
Primary endpoints were included in our study as they are the principal analytical criteria for labeling modification. Secondary endpoints are outcomes that are related to the primary question and are often used to support the conclusions derived from the primary question. They are, however, often not sufficient to support a labeled claim. Therefore, we did not include them in this primary analysis. We still emphasize the importance of secondary endpoints, as they can play an integral role in the evaluation of an agent’s efficacy.

Applications Selected for “Patients Per Pivotal Trial” and “Trial Design” Analysis
For our analysis of the number of patients used in pivotal trials as well as the trial design, we chose application submissions that led to either initial approval of a product (e.g., a Type 1, 3 or 5 submission) or a supplemental approval that resulted in a new indication or usage. Actions that were based solely on pharmacokinetic analysis (e.g., NDA022067, BLA125554, NDA019157, BLA125514, BLA125377) were excluded.

Missing Data

Data on investigational agents approved prior to the Kefauver-Harris Amendments were not obtainable (n = 23). Therefore, efficacy data and trial design on these drugs, known as DESI (Drug Efficacy Study Implementation) drugs are limited. Furthermore, certain data regarding trial design, type of submission and subject enrollment for therapies approved in the mid-to-late 20th century were also not available. We understand that this is a caveat of this figure. Missing data can be appreciated for all actions by looking at Table 1.

Data Visualizations
Figures were generated with the package ‘ggplot2’, using the R programming language, version 4.0.0 (R Foundation for Statistical Computing).

Additional Clarifications 
In regards to NDA 022483/S-003. The initial application for Zyclara included trials studying both 3.75% and the 2.5% dosage forms. The sponsor submitted for an initial NDA for the 3.75% cream. S-003 was a supplemental approval for the 2.5% dosage form. The initial NDA (NDA 022483) included 319 patients. The updated label for S-003 includes data on 479 patients. The drug development program compared both the 3.75% (n = 160) and the 2.5% (n = 160) dosage forms against subjects who received a vehicle control (n = 159). Since there are two different NDA numbers and dates of approval, we have used 319 and 160 respectively so that the total number patients in the studies would be 479, which is reflected in the label.

RESULTS

FDA Approvals in Skin Cancer

Since 1949 there have been 78 drugs approved with an indication or usage for skin cancer. We identified 1518 modifications to the marketing labels of those therapies, including approvals for use, as well as labeling updates (Table 2). To gain further insight into regulatory decisions governing approval, we focused our analysis on the 130 FDA actions that resulted in the approval of a product for a new or revised indication or usage, a formulation change, or dosage change in eight distinct types of cutaneous neoplasia with at least 1 FDA-approved agent at the time of our analysis (Figures 1 & 2).

Figure 2. FDA Approvals Per Decade

Figure 2. FDA Approvals Per Decade
The number of regulatory decisions relating to indications and usage, formulation changes, dosage and administration made in skin cancer drug labels per decade are shown, with color indicating the skin neoplasia corresponding to that action. Parenthetically in the legend is the total number of actions per disease from 1949-2021 by skin cancer type.



Among the 130 FDA approvals in our analysis, 66% occurred in two diseases: melanoma (n = 45) and cutaneous T-cell lymphoma (CTCL) (n = 41). There were 38 new molecular entity (NME) approvals and 63 approvals of efficacy supplements for skin cancer. This constituted 78% of the approvals over the last 70 years (Figure 3).

Figure 3. Type of Labeling Modification

Figure 3. Type of Labeling Modification
This figure depicts the different types of modifications made in skin cancer product labels across the 8 categories of skin neoplasia that have approved therapies, as well as approvals for therapies without specific skin cancer indications (aka “agnostic”), but with relevant use in skin cancer populations. Parenthetically in the legend is the total number of validated labeling modifications corresponding to that type from 1949-2021.




The rate of FDA approvals for skin cancers has changed prominently over time (Figure 2). There were 3 FDA approvals in cutaneous oncology during the 1940s. In the 1950s there were an average of 1.7 actions per year, followed by 0.3 to 1.4 actions annually up until 2010. In the final full decade of our analysis (2011 – 2020), FDA approvals per year increased substantially to 6.5. Indeed, 62% (81/130) of the approvals in our analysis occurred in the last two decades, and 73% (95/130) since the enactment of the first Prescription Drug User Fee Act (PDUFA) on October 29, 1992. The average rate of approvals has steadily increased over the last four rounds of PDUFA re-authorization (Figure 1).

Primary Endpoints Used in FDA Approvals

The proposed efficacy labeling claims for an investigational agent are typically based on the pre-specified, primary endpoint(s) of a trial intended to support approval. Primary endpoints are the basis for the design, statistical parameters including sample size, and success of a trial. Commensurate with the heterogeneity of the clinical manifestations of skin cancer, a variety of endpoints have emerged over time to support marketing approvals. The most common primary endpoint used across skin cancer pivotal trials, and throughout each decade in the analysis time range, was overall response rate (ORR) (Figure 4). The use of co-primary endpoints, as well as progression-free survival (PFS) as the primary efficacy outcome, have emerged only in the last decade.

Figure 4. Primary Endpoints Used in Regulatory Decisions for Skin Cancer Products

Figure 4. Primary Endpoints Used in Regulatory Decisions for Skin Cancer Products
Depicted is the cumulative number and type of primary endpoints used in pivotal trials for skin cancer by decade. Bars are filled with colors corresponding to the type of primary endpoint used in the pivotal trials for NDA or BLA submission from 1951-2020. Co-primary represents trials that used more than one primary endpoint in a pivotal trial. Parenthetically in the legend is the total number of times the specific endpoint was utilized since 1951. Abbreviations - CCR: complete clearance rate, ORR: overall response rate, OS: overall survival, PFS: progression-free survival, PK: pharmacokinetic analysis, RFS: relapse-free survival.



Of 89 reviewable labeling modifications, 64% (57/89) incorporated some form of tumor response claim (e.g., overall response or complete clearance rate). Overall survival, a gold-standard endpoint to measure direct clinical benefit of systemic therapies in oncology trials, was used in 10 applications (5 applications where it was the sole endpoint and 5 applications were it served as a co-primary endpoint), and has only been used in the most recent decade.

Approval Pathways Used in FDA Approvals

All FDA-approved products must meet statutory standards for safety and effectiveness. A regular approval is supported by endpoints that measure direct clinical benefit (e.g., improved survival, symptoms or functional impairments) in the intended use population. The Accelerated Approval (AA) pathway was established in 1992 for therapies used to treat serious and life-threatening conditions with an unmet medical need (21 CFR 314 Subpart H for drugs and 21 CFR 601 Subpart E for biologics). As amended by FDASIA, the FD&C Act provides FDA the authority to grant an AA based upon “determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.”4 Since 1992, there have been 95 FDA approvals of marketing applications seeking new or updated skin cancer indications or usage, including 21 via the AA pathway. The vast majority of AAs occurred in the last 10 years (19/21), including 67% in the last five years (Figure 5).

Figure 5. Accelerated Approval Pathway

Figure 5. Accelerated Approval Pathway
This graph depicts the cumulative number of applications specific for indications and usages in skin neoplasia that were approved via the accelerated pathway from 1991-2020.

Criteria Used in Assessment of Trial Endpoints

Consistent with the diversity in endpoints used to support labeling claims, a number of criteria have been used to evaluate trial endpoints, with Clinical Assessment (e.g., evaluation of alive/dead status) being the most commonly used (Figure 6). Since skin lesions are not always amenable to reliable radiographic evaluation, visual assessment and clinical photography have played essential roles in response assessment. Standardized photographs of baseline and treated skin lesions are recommended in scoring assessment tools in CTCL (e.g., mSWAT and GRS)5. These criteria were used in the trials supporting the approvals of vorinostat, brentuximab vedotin and mogamulizumab-kpkc in CTCL.6,7,8 A composite criteria of bi-dimensional measurements of tumor ulceration and standardized digital photography oftarget lesion(s) in patients with locally advanced BCC (laBCC) was used to support the 2012 NDA for vismodegib. Similarly, a protocol-specific modified RECIST was incorporated for assessing patients with laBCC in the 2015 NDA for sonidegib. This modification of RECIST utilizes multiple data sources including digital photography, magnetic resonance imaging, and pathology from tumor biopsies to develop a composite endpoint called “composite overall response”. Notably, although long used as a method of standardizing assessments of tumor response in skin cancer lesions, digital photographic evaluations conducted during recent pivotal trials served as part of the totality of data supporting FDA granting regular approvals to hedgehog inhibitors for advanced BCC and PD-1 monoclonal antibodies for advanced CSCC and laBCC.9,10,11,12 While ORR more commonly serves as an intermediate endpoint supporting AA in other cancer indications, the dramatic and treatment-related improvements in baseline disfiguring BCC and CSCC lesions observed in the photographic data included in the marketing applications, and the durability of these effects, was considered evidence of direct clinical benefit in these skin cancer populations.

Figure 6. Criteria Used for Assessment of Primary Endpoint



Figure 6. Criteria Used for Assessment of Primary Endpoint
Criteria used for primary endpoint assessments are shown by decade of FDA Approval from 1981-2020. Parenthetically in the legend is the total number of times that tool was used by the applications in this study since 1981. Abbreviations: 2D Measurement: Sum of two dimensional tumor measurements, ACTG: AIDS Clinical Trials Group Oncology Committee of the National Institute of Allergy and Infectious Diseases criteria (this group includes both ACTG and modified ACTG), CCR: complete clearance rate, Clinical: this connotes an investigator assessment without a specific tool, e.g., detection of a recurrent lesion in an adjuvant study or absence of a lesion for complete clearance rate assessment), Composite: composite endpoint, GRS: global response criteria, mRECIST: modified RECIST, mSWAT: modified SWAT, ORR: overall response rate, OS: overall survival, PK: pharmacokinetic analysis, PFS: progression-free survival, RECIST: Response Evaluation Criteria in Solid Tumors, RFS: relapse-free survival, SWAT: severity-weighted assessment tool, WHO: world health organization; WSSI: weighted skin severity index.


Patients Per Pivotal Trial

Pivotal trials have varied greatly in the number of subjects used to support the statistical persuasiveness of the investigational agent’s effect. Of the 77 trials where data on enrollment were obtainable and met our inclusion criteria, the smallest application in this cohort was the imatinib supplemental NDA for dermatofibrosarcoma protuberans (n = 18). The largest study supported the 2011 supplemental BLA for peginterferon alfa-2B use in resected melanoma (n = 1256) (Figure 7).

Figure 7. Subjects Enrolled in Pivotal Trials Click Here for Figure 7

Figure 7. Subjects Enrolled in Pivotal Trials
The number of patients in each pivotal trial is depicted as a red dot grouped by decade of FDA Approval from 1971-2020.

Efficacy Assessment in Non-Comparator Trials

Information regarding design of the pivotal trial was available for 79 approvals in our analysis. Of those, 24 labeling modifications were supported by placebo-controlled trials, 25 by trials of the study drug versus an active-comparator, and 30 by non-randomized studies. Single-arm trials often measure efficacy based on tumor response rate and duration of response since time-to-event endpoints (e.g., survival) are challenging to interpret in the absence of an internal control (whereas most tumors rarely shrink in the absence of therapy). Of the 30 labeling modifications supported by results of single-arm studies, the observed ORR ranged from 15.9-83.3%, with a median of 34% (Figure 8). ORR results are typically evaluated in the context of a pre-specified target overall response rate and a lower bound 95% confidence interval (lb95%CI) considered clinically relevant in the respective indication. We identified 15 labeling modifications in which the lb95%CI was pre-specified in the protocol. A lb95%CI that excluded response rates less than 15% was the most commonly used boundary (n = 5) in the statistical plans; the range was 5% (n=4) to 25% (n=2). The lb95%CI appears to be increasing in the protocols over time with 5% last used in 2006. Between 2016 and 2020 the minimum lb95%CI was 15%. Furthermore, the median lb95CI has increased from 5% in 1996-2000 to 17.5% in 2016-2020.

Figure 8. Efficacy Assessment in Non-Comparator Trials Click Here for Figure 8

Figure 8. Efficacy Assessment in Non-Comparator Trials
Depicted is the overall response rate (filled circles) in non-comparator trials with the corresponding 95% confidence interval (dotted segments) and the lb95%CI proposed by the sponsor to estimate a clinically meaningful response rate (“X”). This is conceptually similar to a null hypothesis for which an investigator would reject if the data were statistically persuasive. For actions, FDA may focus on the observed response rate and associated confidence interval rather than original statistical design of the protocol. Abbreviations. AIDS KS: AIDS-related kaposi sarcoma, AIDS KS (AA): AIDS-related kaposi sarcoma, trial approved with accelerated approval, HIV-pos KS: HIV-positive Kaposi Sarcoma, HIV-neg KS, HIV-negative Kaposi Sarcoma, laBCC: locally advanced basal cell carcinoma, laCSCC: locally advanced cutaneous squamous cell carcinoma, la/mMCC: locally advanced or metastatic Merkel cell carcinoma, lb95%CI: lower bound 95% confidence interval, mBCC: metastatic basal cell carcinoma, mCSCC: metastatic cutaneous squamous cell carcinoma, MSI-hi: microsatellite instability high, r/mCSCC: recurrent or metastatic cutaneous squamous cell carcinoma, rCTCL: refractory cutaneous T-cell lymphoma, TMB-hi: tumor mutation burden high, u/mDFSP: unresectable or metastatic dermatofibrosarcoma Protuberans, u/mMelanoma: unresectable or metastatic melanoma.

Discussion

The therapeutic landscape in skin cancer has changed greatly since the first approval in 1949. In concert, regulatory medicine has evolved over the last 70 years with the aim of ensuring access to safe and effective medicines for a diverse array of patients. While approvals for CTCL have occurred steadily over the last 70 years, therapeutic innovation in melanoma has been a more recent development, with 91% of actions occurring in the last ten years. Furthermore, in just the last five years, initial approvals occurred in Merkel cell carcinoma, cutaneous squamous cell carcinoma, and tissue agnostic indications with direct relevance to skin cancer.

The 1962 Statutory Effectiveness Standard FDCA Sec 505(b) put into law that a sponsor must provide “substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling”. The primary basis for determining whether there is “substantial evidence” to support the claims of effectiveness for new drugs are reports of adequate and well-controlled investigations. Therefore, although there are statutes codified into law that provide guidance to the FDA, benefit-risk assessments must be interpreted through the contextual lens of the disease environment specific for any given labeled indication. Isolation of the purported effect may dictate that trials be designed with multiple arms, incorporating either a placebo or active-comparator control. Randomization is generally necessary for a reliable analysis of time-to-event endpoints in oncology trials (e.g. PFS or OS). Use of OS in clinical trials in cutaneous oncology has generally occurred in the past decade. This is likely context dependent, as improvements in OS have supported melanoma approvals which have most occurred over the prior decade. As melanoma is a systemic disease, approvals generally require data to support a systemic anti-tumor effect (and survival is a gold standard for such an effect).

The phrase “adequate and well-controlled studies” has commonly been interpreted as a requirement for external duplication through at least two independent trials. However, FDA may also rely on a single clinical trial to establish effectiveness in certain circumstances. In cutaneous oncology specifically, single-arm trials demonstrating a clinically relevant effect size on ORR that is durable have successfully supported marketing approvals of several new molecular entities and supplemental indications.

Depending on the context, ORR in cancer studies may be considered a surrogate or intermediate clinical endpoint that is “reasonably likely to predict clinical benefit”; therefore, an effect on ORR has the potential to support an AA with requirements to verify and describe benefit in subsequent post-marketing studies. It is noteworthy however, that for some skin cancer indications, there are multiple examples of regular approvals based on demonstration of durable response rates in the intended use population. As discussed above, for recent drug approvals for advanced BCC and CSCC, FDA evaluated the totality of data for these products in the context of patients having a life-threatening cancer as well as other serious disease burdens. Demonstration of durable ORRs that correlated with substantial reduction in size of disfiguring cutaneous tumors in highly visible areas, was considered direct evidence of clinical benefit and supported these regular approvals. Ultimately, the choice of endpoint in any specific development program will depend upon multiple factors including ability to accurately assess the endpoint, unmet need, rarity of the disease, and the relative efficacy of the drug.

Because cutaneous oncology is diverse with respect to goals of therapy, available therapies, unmet need, and prevalence of the different diseases, there are different considerations for each disease with respect to study designs including number of patients needed to demonstrate efficacy. For example, the smallest trial in this cohort, the 2006 supplemental NDA for imatinib in DFSP, consisted of 18 subjects. This application was supported by data from 12 subjects in a single-arm trial and 6 from case reports. Central to the regulatory decision was the fact that there were no available therapies approved for DFSP (an ultra-rare disease), the biology was well characterized, the safety profile of imatinib was well known, and the results were statistically persuasive and consistent with similar response rates in other approved conditions of use. For example, 83% (15/18) of the patients in the application had a response with 47% (7/15) of responders demonstrating a complete response.

For rare cutaneous malignancies, global drug development strategies may be needed and developers may use novel trial designs to assess the effects of a drug. Such designs may include basket or umbrella trials, trials with Bayesian designs, or trials that generate evidence for tissue agnostic approvals. As stated in Figure 1, one goal of the 21st Century Cures Act is to evaluate the use of “Real World Evidence” (RWE) to support regulatory decisions. For example, photographic evidence of clinical benefit, a unique feature of cutaneous oncology, could be incorporated into RWE.

Caveats of this study include the fact that data were not obtainable for every approved product. Additionally, although safety is a critical component of the benefit-risk evaluation, this study focused on the assessment of clinical benefit, with a scope limited primarily to efficacy.
In summary, regulatory decisions regarding the indications and usage of anti-neoplastic agents occur in a dynamic environment. An improved understanding of the trends of regulatory medicine by dermatologists and oncologists may yield more effective clinical investigations for patients with skin cancer.

Table 1. Therapies with Indications for Skin Cancer
Therapeutic(s) BLA/NDA Indication Submission Class Action Date Skin Neoplasia Primary Endpoint Major Efficacy Outcome Measure Subjects Enrolled Lower Bound 95% CI (%) Assessment Tool Accelerated Approval Mechanism
MECHLORETHAMINE HYDROCHLORIDE NDA006695 Mycosis fungoides Type 1 - New Molecular Entity 1949-03-15 CTCL NA NA NA NA NA No Alkylating Agent
CORTISONE ACETATE NDA007110 Mycosis fungoides Type 1 - New Molecular Entity 1950-06-13 CTCL NA NA NA NA NA No Glucocorticoid
CORTISONE ACETATE NDA007750 Mycosis fungoides Type 3 - New Dosage Form 1950-12-04 CTCL NA NA NA NA NA No Glucocorticoid
HYDROCORTISONE NDA008697 Mycosis fungoides Type 5 - New Formulation or New Manufacturer 1952-12-15 CTCL NA NA NA NA NA No Glucocorticoid
METHOTREXATE SODIUM NDA008085 Mycosis fungoides Type 1 - New Molecular Entity 1953-12-07 CTCL Response Rate NA NA NA NA No Antimetabolite
PREDNISONE NDA009766 Mycosis fungoides Type 1 - New Molecular Entity 1955-02-21 CTCL NA NA NA NA NA No Glucocorticoid
HYDROCORTISONE SODIUM SUCCINATE NDA009866 Mycosis fungoides Type 2 - New Active Ingredient 1955-04-27 CTCL NA NA NA NA NA No Glucocorticoid
PREDNISOLONE NDA009987 Mycosis fungoides Type 1 - New Molecular Entity 1955-06-21 CTCL NA NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE NDA011153 Mycosis fungoides Type 1 - New Molecular Entity 1957-10-24 CTCL NA NA NA NA NA No Glucocorticoid
TRIAMCINOLONE NDA011161 Mycosis fungoides Type 1 - New Molecular Entity 1957-12-03 CTCL NA NA NA NA NA No Glucocorticoid
DEXAMETHASONE NDA011664 Mycosis fungoides Type 1 - New Molecular Entity 1958-10-30 CTCL NA NA NA NA NA No Glucocorticoid
TRIAMCINOLONE DIACETATE NDA011685 Mycosis fungoides Type 2 - New Active Ingredient 1959-03-12 CTCL NA NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE SODIUM SUCCINATE NDA011856 Mycosis fungoides Type 2 - New Active Ingredient 1959-05-18 CTCL NA NA NA NA NA No Glucocorticoid
METHYLPREDNISOLONE ACETATE NDA011757 Mycosis fungoides Type 2 - New Active Ingredient 1959-05-27 CTCL NA NA NA NA NA No Glucocorticoid
METHOTREXATE SODIUM NDA011719 Mycosis fungoides Type 2 - New Active Ingredient 1959-08-10 CTCL Response Rate NA NA NA NA No Antimetabolite
DEXAMETHASONE SODIUM PHOSPHATE NDA012071 Mycosis fungoides Type 3 - New Dosage Form 1959-10-06 CTCL NA NA NA NA NA No Glucocorticoid
CYCLOPHOSPHAMIDE NDA012142 Mycosis fungoides Type 2 - New Active Ingredient 1959-11-16 CTCL NA NA NA NA NA No Alkylating Agent
CYCLOPHOSPHAMIDE NDA012141 Mycosis fungoides Type 1 - New Molecular Entity 1959-11-16 CTCL NA NA NA NA NA No Alkylating Agent
METHYLPREDNISOLONE ACETATE NDA012421 Mycosis fungoides Type 3 - New Dosage Form 1960-06-21 CTCL NA NA NA NA NA No Glucocorticoid
DEXAMETHASONE NDA012376 Mycosis fungoides Type 3 - New Dosage Form 1960-07-07 CTCL NA NA NA NA NA No Glucocorticoid
BETAMETHASONE NDA012657 Mycosis fungoides Type 1 - New Molecular Entity 1961-04-17 CTCL NA NA NA NA NA No Glucocorticoid
TRIAMCINOLONE DIACETATE NDA012802 Mycosis fungoides Type 5 - New Formulation or New Manufacturer 1961-09-05 CTCL NA NA NA NA NA No Glucocorticoid
TRIAMCINOLONE ACETONIDE NDA014901 Mycosis fungoides Type 5 - New Formulation or New Manufacturer 1965-02-01 CTCL NA NA NA NA NA No Glucocorticoid
BETAMETHASONE ACETATE NDA014602 Mycosis fungoides Type 1 - New Molecular Entity 1965-03-03 CTCL NA NA NA NA NA No Glucocorticoid
VINBLASTINE SULFATE NDA012665 Mycosis fungoides Type 1 - New Molecular Entity 1965-11-25 CTCL NA NA NA NA NA No Microtubule Inhibitor
VINBLASTINE SULFATE NDA012665 Kaposi’s sarcoma Type 1 - New Molecular Entity 1965-11-25 KS NA NA NA NA NA No Microtubule Inhibitor
HYDROXYUREA NDA016295 Melanoma Type 1 - New Molecular Entity 1967-12-07 Melanoma Overall Response Rate NA NA NA NA No Anti-Metabolite
FLUOROURACIL NDA016831 Multiple actinic keratoses Type 3 - New Dosage Form 1970-07-29 AK NA NA NA NA NA NA Anti-Metabolite
FLUOROURACIL NDA016988 Actinic keratoses Type 5 - New Formulation or New Manufacturer 1971-08-06 AK NA NA NA NA NA No Anti-Metabolite
DACARBAZINE NDA017575 Metastatic malignant melanoma Type 1 - New Molecular Entity 1975-05-27 Melanoma Overall Response Rate NA NA NA NA No Alkylating Agent
FLUOROURACIL NDA016831 Superficial basal cell carcinoma Efficacy 1975-06-30 BCC Complete Clearance Rate CCR: 93% 54 NA NA No Anti-Metabolite
PREDNISOLONE SODIUM PHOSPHATE NDA019157 Mycosis fungoides Type 3 - New Dosage Form 1986-05-28 CTCL Bioequivalence NA 12 NA PK No Glucocorticoid
METHOXSALEN NDA009048 Refractory cutaneous t-cell lymphoma Efficacy 1988-03-23 CTCL Response Rate NA NA NA NA No Phototoxic Agent
INTERFERON ALFA-2B BLA103132 AIDS-related kaposi’s sarcoma Efficacy 1988-11-21 KS Response Rate

RR: 29% (30 million IU study)

RR: 30% (35 million IU study)
144 NA NA No Cytokine
INTERFERON ALFA-2A BLA103145 AIDS-related kaposi’s sarcoma Efficacy 1988-11-21 KS Response Rate RR: 25.5% (35 MIU) 350 NA NA No Cytokine
DOXORUBICIN HYDROCHLORIDE NDA050718 Accelerated approval for refractory AIDS-related kaposi’s sarcoma Type 3 - New Dosage Form 1995-11-17 KS Response Rate

RR: 27% (Investigator Assessment)

RR: 48% (Indicator Lesion Assessment)
77 NA ACTG Yes Topoisomerase Inhibitor
INTERFERON ALFA-2B BLA103132 Adjuvant melanoma Efficacy 1995-12-05 Melanoma Relapse-Free Survival

RFS: 1.72 vs. 0.98 years

OS: 3.82 vs. 2.78 years

280

(T=143

C=137)
NA Clinical No Cytokine
DAUNORUBICIN CITRATE NDA050704 Hiv-associated kaposi’s sarcoma - first line Type 3 - New Dosage Form 1996-04-08 KS Response Rate RR: 23%

227

(T=116

C=111)
NA ACTG No Topoisomerase Inhibitor
PACLITAXEL NDA020262 AIDS-related kaposi’s sarcoma - second line Efficacy 1997-08-04 KS Response Rate RR: 59% 59 NA ACTG No Microtubule Stabilizer
ALDESLEUKIN BLA103293 Metastatic melanoma Efficacy 1998-01-09 Melanoma Objective Response Rate RR: 15.9% 270 NA 2D Measurement No Cytokine
PREDNISOLONE SODIUM PHOSPHATE NDA019157 Expansion to include pediatric populations Efficacy 1998-12-17 CTCL NA NA NA NA NA No Glucocorticoid
ALITRETINOIN NDA020886 AIDS-related kaposi’s sarcoma - cutaneous lesions only Type 1 - New Molecular Entity 1999-02-02 KS Response Rate

RR: 35% (Study 1)

RR: 36% (Study 2)

350

(T=170

C=180)
NA ACTG No Retinoid
DENILEUKIN DIFTITOX BLA103767 Accelerated approval for persistent or recurrent CD25+ cutaneous t-cell lymphoma Type 1 - New Molecular Entity 1999-02-05 CTCL Response Rate RR: 36% (18 mcg) RR: 23% (9 mcg)

71

(18mcg=36

9mcg=35)
NA SWAT Yes Cytokine-Cytotoxin
METHOXSALEN NDA020969 Refractory cutaneous t-cell lymphoma Type 3 - New Dosage Form 1999-02-25 CTCL Response Rate RR: 33.3% 51 25 Composite No Phototoxic Agent
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Non-hyperkeratotic actinic keratoses of the face or scalp Type 1 - New Molecular Entity 1999-12-03 AK Complete Response Rate

CCR: 69% (Trial 1)

CCR: 63% (Trial 2)

241

(T=180

C=61)
NA Clinical No Phototoxic Agent
BEXAROTENE NDA021055 Refractory cutaneous t-cell lymphoma Type 1 - New Molecular Entity 1999-12-29 CTCL Response Rate RR: 32.2% 152 5 Composite No Retinoid
BEXAROTENE NDA021056 Refractory stage ia and ib cutaneous t-cell lymphoma Type 3 - New Dosage Form 2000-06-28 CTCL Response Rate RR: 26% 50 5 Composite No Retinoid
DICLOFENAC SODIUM NDA021005 Actinic keratoses Type 3 - New Dosage Form 2000-10-16 AK Complete Clearance Rate

CCR: 47% (Study 1 90d Tx)

CCR: 34% (Study 2 90d Tx)

CCR: 31% (Study 3 60d Tx)

CCR: 14% (Study 3 30d Tx)

427

(T=213

C=214)
NA Clinical No NSAID
FLUOROURACIL NDA020985 Multiple actinic keratoses of the face and anterior scalp Type 3 - New Dosage Form 2000-10-27 AK Complete Clearance Rate

CCR: 58% (Study 1)

CCR: 38% (Study 2)

384

(T=257

C=127)
NA Clinical No Anti-Metabolite
IMIQUIMOD NDA020723 Nonhypertrophic actinic keratoses on the face or scalp Efficacy 2004-03-02 AK Complete Clearance Rate

CRR: 46% (Study A)

CCR: 44% (Study B)

436

(T=215

C=221)
NA Clinical No TLR Agonist
IMIQUIMOD NDA020723 Superficial basal cell carcinoma Efficacy 2004-07-14 BCC Complete Clearance Rate

CCR: 70% (Study C)

CCR: 80% (Study D)

364

(T=185

C=179)
NA Composite No TLR Agonist
METHYL AMINOLEVULINATE HYDROCHLORIDE NDA021415 Non-keratotic actinic keratoses of the face and scalp Type 3 - New Dosage Form 2004-07-27 AK Complete Response Rate

CRR: 81% (Australian Study)

CCR: 79% (U.S. Study)

191

(T=130

C=61)
NA Clinical No Phototoxic Agent
PREDNISOLONE SODIUM PHOSPHATE NDA021959 Mycosis fungoides Type 3 - New Dosage Form 2006-06-01 CTCL Bioequivalence NA NA NA PK No Glucocorticoid
VORINOSTAT NDA021991 Refractory cutaneous t-cell lymphoma Type 1 - New Molecular Entity 2006-10-06 CTCL Response Rate

RR: 29.7% (Study 1)

RR: 24.2% (Study 2)
107 5 mSWAT No Hedgehog Inhibitor
IMATINIB MESYLATE NDA021588 Unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans Efficacy 2006-10-19 DFSP Overall Response Rate RR: 83.3% 18 NA NA No Kinase Inhibitor
PREDNISOLONE ACETATE NDA022067 Mycosis fungoides Type 3 - New Dosage Form 2008-01-17 CTCL Bioequivalence NA 72 NA NA No Glucocorticoid
DOXORUBICIN HYDROCHLORIDE NDA050718 Regular aprroval for refractory AIDS-related kaposi’s sarcoma Efficacy 2008-06-10 KS Overall Response Rate

RR: 41% (Study 1)

RR: 36% (Study 2)
28 NA NA No Topoisomerase Inhibitor
TRIAMCINOLONE ACETONIDE NDA022220 Mycosis fungoides Type 3 - New Dosage Form 2008-06-16 CTCL NA NA NA NA NA No Glucocorticoid
METHYL AMINOLEVULINATE HYDROCHLORIDE NDA021415 Use of metvixia with a new lamp (aktilite) in AKs Efficacy 2008-06-26 AK Complete Response Rate CCR: 59.2% (Study 1) CCR: 68.4% (Study 2) 211 (T=106 C=105) NA Clinical No Phototoxic Agent
DENILEUKIN DIFTITOX BLA103767 Regular approval for persistent or recurrent CD25+ cutaneous t-cell lymphoma Efficacy 2008-10-15 CTCL Response Rate RR: 46% (18 mcg) RR: 37% (9 mcg)

144

(18mcg=55

9mcg=45 C=44)
NA WSSI No Cytokine-Cytotoxin
ROMIDEPSIN NDA022393 Refractory cutaneous t-cell lymphoma Type 1 - New Molecular Entity 2009-11-05 CTCL Objective Response Rate

RR: 34% (Pivotal Study)

RR: 35% (Supportive Study)
167 15 Composite No HDAC Inhibitor
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Allow user to mix contents for 30 seconds prior to use & to use ‘kerastick krusher’ Efficacy 2010-03-12 AK NA NA NA NA NA No Phototoxic Agent
IMIQUIMOD NDA022483 Use of 3.75% form for actinic keratoses of the full face or balding scalp Type 5 - New Formulation or New Manufacturer 2010-03-25 AK Complete Clearance Rate

CCR: 25.9% (Study 1)

CCR: 45.6% (Study 2)

319

(T=160

C=159)
NA Clinical No TLR Agonist
IPILIMUMAB BLA125377 Unresectable or metastatic melanoma Type 1 - New Molecular Entity 2011-03-25 Melanoma Overall Survival HR: 0.66

676

(I=137

IGP=403

GP=136)
NA Clinical No CTLA-4 Targeted Antibody
PEGINTERFERON ALFA-2B BLA103949 Adjuvant melanoma Efficacy 2011-03-29 Melanoma Relapse-Free Survival HR: 0.82

1256

(T=627

C=629)
NA Clinical No Cytokine
IMIQUIMOD NDA022483 Use of 2.5% cream for AKs on face and scalp Efficacy 2011-07-15 AK Complete Clearance Rate

CCR: 23% (Study 1)

CCR: 38% (Study 2)

319

(T=160

C=159)
NA Clinical No TLR Agonist
VEMURAFENIB NDA202429 Unresectable or metastatic melanoma Type 1 - New Molecular Entity 2011-08-17 Melanoma Overall Survival & Progression-Free Survival

HR: 0.44 (OS)

HR: 0.26 (PFS)

675

(T=337

C=338)
NA RECIST No Kinase Inhibitor
INGENOL MEBUTATE NDA202833 Actinic keratoses Type 1 - New Molecular Entity 2012-01-23 AK Complete Clearance Rate

CCR: 37% (Study 1 Head and Neck)

CCR: 47% (Study 2 Head & Neck)

CCR: 28% (Study 3 Trunk & Extremities)

CCR: 42% (Study 4 Trunk & Extremities)

1005

(H/N

T=277

C=270

T/E

T=226

C=232)
NA Clinical No Cytotoxic Agent
VISMODEGIB NDA203388 Locally advanced or metastatic basal cell carcinoma Type 1 - New Molecular Entity 2012-01-30 BCC Objective Response Rate

RR: 30.3% (mBCC)

RR: 42.9% (laBCC)

96

(mBCC=33

laBCC=63)
10 20 mRECIST No Hedgehog Inhibitor
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or metastatic BRAF-mutated melanoma Type 1 - New Molecular Entity 2013-05-29 Melanoma Progression-Free Survival HR: 0.47

322

(T=214

C=108)
NA RECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Single agent, first-line in advanced BRAF-mutated melanoma Type 1 - New Molecular Entity 2013-05-29 Melanoma Progression-Free Survival HR: 0.33

250

(T=187

C=63)
NA RECIST No Kinase Inhibitor
MECHLORETHAMINE HYDROCHLORIDE NDA202317 Refractory stage ia and ib cutaneous t-cell lymphoma Type 5 - New Formulation or New Manufacturer 2013-08-23 CTCL Response Rate RR: 60%

242

(T=119

C=123)
NA Composite No Alkylating Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or metastatic BRAF-mutated melanoma Efficacy 2014-01-08 Melanoma Objective Response Rate & Progression-Free Survival ORR: 76%

162

(DT2=55

DT1=54 D=53)
NA RECIST Yes MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Accelerated approval for dab/tram in advanced BRAF mutant melanoma Efficacy 2014-01-09 Melanoma Objective Response Rate RR: 76%

162

(DT2=55

DT1=54

D=53)
NA RECIST Yes Kinase Inhibitor
PEMBROLIZUMAB BLA125514 Unresectable or metastatic melanoma - second line Type 1 - New Molecular Entity 2014-09-04 Melanoma Overall Response Rate RR: 23.6% 173 10 mRECIST Yes PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated approval for unresectable or metastatic melanoma in the second-line setting Type 1 - New Molecular Entity 2014-12-22 Melanoma Overall Response Rate RR: 32% 120 15 RECIST Yes PD-1 Targeted Antibody
SONIDEGIB PHOSPHATE NDA205266 Locally advanced basal cell carcinoma Type 1 - New Molecular Entity 2015-07-24 BCC Objective Response Rate RR: 57.5% 194 20 mRECIST No Smoothened Inhibitor
NIVOLUMAB BLA125554 Accelerated approval of OPDIVO with yervoy in BRAF wild type unresectable or metastatic melanoma Efficacy 2015-09-30 Melanoma Objective Response Rate RR: 60%

109

(T=72

C=37)
NA RECIST Yes PD-1 Targeted Antibody
TALIMOGENE LAHERPAREPVEC BLA125518 Unresectable cutaneous, subcutaneous, and nodal recurrent melanoma Type 1 - New Molecular Entity 2015-10-27 Melanoma Durable Response Rate RR: 16.3%

436

(T=295

C=141)
NA WHO No Oncolytic Virus
IPILIMUMAB BLA125377 Adjuvant melanoma Efficacy 2015-10-28 Melanoma Relapse-Free Survival HR: 0.75

951

(T=475

C=476)
NA Clinical No CTLA-4 Targeted Antibody
COBIMETINIB FUMARATE NDA206192 Unresectable or metastatic melanoma with a BRAF-mutated melanoma in combination with vemurafenib Type 1 - New Molecular Entity 2015-11-10 Melanoma Progression-Free Survival HR: 0.56

495

(T=247

C=248)
NA RECIST No Kinase Inhibitor
INGENOL MEBUTATE NDA202833 Describing response to a repeat course Efficacy 2015-11-19 AK Complete Clearance Rate NA NA NA Clinical No Cytotoxic Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Unresectable or metastatic melanoma with a BRAF-mutated melanoma in combination with daBRAFenib Efficacy 2015-11-20 Melanoma Progression-Free Survival HR: 0.75

423

(DT=211

DP=212)
NA RECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Regular approval for dab/tram in advanced BRAF mutant melanoma Efficacy 2015-11-20 Melanoma Overall Survival

HR: 0.71 (Trial 2)

HR: 0.69 (Trial 3)

1127

(Trial 2

DT=211

DP=212

Trial 3

DT=352

Vem=352)
NA RECIST No Kinase Inhibitor
NIVOLUMAB BLA125554 Regular approval for unresectable or metastatic BRAF-wild type melanoma Efficacy 2015-11-23 Melanoma Overall Survival HR: 0.42

418

(T=210

C=208)
NA RECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Unresectable or metastatic melanoma Efficacy 2015-12-18 Melanoma Progression-Free Survival & Overall Survival

HR: 0.57 (2 mg/kg)

HR: 0.50 (10 mg/kg)

540

(P2=180

P10=181 C=179)
NA mRECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Removing language limiting the indication to disease progression following ipilimumab Efficacy 2015-12-18 Melanoma Progression-Free Survival & Overall Survival

HR: 0.69 (OS)

HR: 0.58 (PFS)

834

(T=556

C=278)
NA mRECIST No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated approved for BRAF mutant unresectable or metastatic melanoma in the first line setting Efficacy 2016-01-23 Melanoma Progression-Free Survival & Overall Survival

HR: 0.57 (BRAF wt & mutant)

HR: 0.77 (BRAF mutant only)

198

(T=98

C=100)
NA RECIST Yes PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Accelerated approval of ipi/nivo expansion for BRAF mutant as well as BRAF wt Efficacy 2016-01-23 Melanoma Progression-Free Survival & Overall Survival HR: 0.42 (BRAF wt & mut) HR: 0.47 (BRAF mut only)

198

(T=98

C=100)
NA RECIST Yes PD-1 Targeted Antibody
AMINOLEVULINIC ACID HYDROCHLORIDE NDA208081 Actinic keratoses of mild-to-moderate severity on the face and scalp Type 3 - New Dosage Form 2016-05-10 AK Complete Response Rate

CCR: 85% (Trial 1)

CCR: 84% (Trial 2)

CCR: 91% (Trial 3)

299

(T=212

C=87)
NA Clinical No Phototoxic Agent
NIVOLUMAB BLA125554 Flat dosing for melanoma, NSCLC and RCC Efficacy 2016-09-13 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Flat dosing for melanoma, NSCLC and RCC Efficacy 2016-09-13 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
AVELUMAB BLA761049 Metastatic merkel cell carcinoma Type 1 - New Molecular Entity 2017-03-23 MCC Overall Response Rate RR: 33% 88 20 RECIST Yes PD-L1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Flat dosing of 200 mg q3 weeks in melanoma Efficacy 2017-05-17 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumors Efficacy 2017-05-23 Agnostic Objective Response Rate & Duration of Response

RR: 39.6%

DoR: Not Reached
149 NA mRECIST Yes PD-1 Targeted Antibody
IPILIMUMAB BLA125377 Unresectable or metastatic melanoma - patients 12 years and older Efficacy 2017-07-21 Melanoma Pharmacokinetic Analysis NA 45 NA PK No CTLA-4 Targeted Antibody
BRENTUXIMAB VEDOTIN BLA125388 CD30+ mycosis fundgoides and pcalcl in the second line Efficacy 2017-11-09 CTCL Durable Response Rate RR: 56.3%

128

(T=66

C=62)
NA GRS No CD30 Targeted Antibody
NIVOLUMAB BLA125554 Regular approval for adjuvant melanoma Efficacy 2017-12-20 Melanoma Relapse-Free Survival HR: 0.65

906

(T=453

C=453)
NA Clinical No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Updates infusion from 60 to 30 minutes Efficacy 2018-01-09 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
COBIMETINIB FUMARATE NDA206192 Updates label to include OS data Efficacy 2018-01-26 Melanoma NA NA NA NA NA No Kinase Inhibitor
NIVOLUMAB BLA125554 Every 4 week dosing for advanced melanoma Efficacy 2018-03-05 Melanoma Pharmacokinetic Analysis NA 4166 NA PK No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Every 4 week dosing in adjuvant melanoma Efficacy 2018-03-05 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Updates infusion from 60 to 30 minutes in adjuvant melanoma Efficacy 2018-03-05 Melanoma NA NA NA NA NA No PD-1 Targeted Antibody
AMINOLEVULINIC ACID HYDROCHLORIDE NDA020965 Minimally to moderately thick actinic keratosis of the upper extremities Efficacy 2018-03-06 AK Complete Response Rate CCR: 31%

269

(T=135

C=134)
NA NA No Phototoxic Agent
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Adjuvant BRAF mutant melanoma in combination with daBRAFenib Efficacy 2018-04-30 Melanoma Relapse-Free Survival HR: 0.47

870

(T=438

C=432)
NA Clinical No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Adjuvant BRAF mutant melanoma in combination with trametinib Efficacy 2018-04-30 Melanoma Relapse-Free Survival HR: 0.47

870

(T=438

C=432)
NA Clinical No Kinase Inhibitor
ENCORAFENIB NDA210496 Regular approval for use in combination with binimetinib for advanced BRAF mutant melanoma Type 1 - New Molecular Entity and Type 4 - New Combination 2018-06-27 Melanoma Progression-Free Survival HR: 0.54

577

(Bin/Enc=192

Enc=192

Vem=191)
NA RECIST No Kinase Inhibitor
BINIMETINIB NDA210498 Unresectable or metastatic BRAF-mutated melanoma in combination with encorafenib Type 1 - New Molecular Entity and Type 4 - New Combination 2018-06-27 Melanoma Progression-Free Survival HR: 0.54

577

(Bin/Enc=192

Enc=192

Vem=191)
NA RECIST No Kinase Inhibitor
MOGAMULIZUMAB-KPKC BLA761051 Relapsed/refractory mycosis fungoides or sezary syndrome - second line Type 1 - New Molecular Entity 2018-08-08 CTCL Progression-Free Survival HR: 0.53

372

(T=186

C=186)
NA GRS No CCR4 Targeted Antibody
CEMIPLIMAB-RWLC BLA761097 Locally advanced or metastatic squamous cell carcinoma Type 1 - New Molecular Entity 2018-09-28 SCC Overall Response Rate

RR: 46.7% (mCSCC)

RR: 48.5% (laCSCC)

108

(mSCC=75

laSCC=33)
15 25 Composite No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Locally advanced or metastatic merkel cell carcinoma Efficacy 2018-12-19 MCC Overall Response Rate & Duration of Response

RR: 56%

DoR: 5.9-34.5+ (months)
50 NA RECIST Yes PD-1 Targeted Antibody
VISMODEGIB NDA203388 To allow for treatment interruptions of up to 8 weeks for intolerable aes Efficacy 2019-01-18 BCC NA NA NA NA NA No Hedgehog Inhibitor
PEMBROLIZUMAB BLA125514 Adjuvant melanoma Efficacy 2019-02-15 Melanoma Relapse-Free Survival HR: 0.57

1019

(T=509

C=502)
NA Clinical No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Conversion to regular approval for the treatment of patients with BRAF v600 mutation-positive unresectable or metastatic melanoma Efficacy 2019-03-07 Melanoma Overall Survival NA 405 (T=272 C=133) NA NA No PD-1 Targeted Antibody
NIVOLUMAB BLA125554 Conversion to regular approval of OPDIVO, in combination with ipilimumab, for the treatment of patients with unresectable or metastatic melanoma Efficacy 2019-03-07 Melanoma Overall Survival NA 945 (IN=314 N=316 I=315) NA Clinical No PD-1 Targeted Antibody
TRAMETINIB DIMETHYL SULFOXIDE NDA204114 Updating results in subjects with brain metastases Efficacy 2019-10-06 Melanoma Overall Response Rate RR: 50% 121 NA mRECIST No MEK Inhibitor
DABRAFENIB MESYLATE NDA202806 Updates label in regards to brain metastases for melanoma Efficacy 2019-10-06 Melanoma Overall Response Rate RR: 50% 121 NA mRECIST No Kinase Inhibitor
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in melanoma Efficacy 2020-04-28 Melanoma Pharmacokinetic Analysis NA 44 NA PK Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in merkel cell carcinoma Efficacy 2020-04-28 MCC NA NA NA NA NA Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in msi-h tumors Efficacy 2020-04-28 Agnostic NA NA NA NA NA Yes PD-1 Targeted Antibody
POMALIDOMIDE NDA204026 Treatment of adult patients with AIDS-related kaposi sarcoma Efficacy 2020-05-14 KS Objective Response Rate RR: 67%

28

(HIV+=18

HIV-=10)
NA ACTG Yes Cereblon Inhibitor
POMALIDOMIDE NDA204026 Treatment of kaposi’s sarcoma in patients who are hiv-negative Efficacy 2020-05-14 KS Objective Response Rate RR: 80%

28

(HIV+=18

HIV-=10)
NA ACTG Yes Cereblon Inhibitor
PEMBROLIZUMAB BLA125514 Tumor mutation burden-high solid tumors Efficacy 2020-06-16 Agnostic Objective Response Rate & Duration of Response RR: 29% 102 NA mRECIST Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing in TMB-hi tumors Efficacy 2020-06-16 Agnostic NA NA NA NA NA Yes PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 R/mCSCC Efficacy 2020-06-24 SCC Objective Response Rate RR: 34.3% 105 15 mRECIST No PD-1 Targeted Antibody
PEMBROLIZUMAB BLA125514 Every 6 weeks dosing for CSCC Efficacy 2020-06-24 SCC NA NA NA NA NA Yes PD-1 Targeted Antibody
ATEZOLIZUMAB BLA761034 Unresectable or metastatic BRAF-mutated melanoma in combination with cobimetinib and vemurafenib Efficacy 2020-07-30 Melanoma Progression-Free Survival HR: 0.78

514

(T=256

C=258)
NA RECIST No PD-L1 Targeted Antibody
TIRBANIBULIN NDA213189 Actinic keratosis of the face or scalp Type 1 - New Molecular Entity 2020-12-14 AK Complete Clearance Rate

CCR: 44% (Study 1)

CCR: 54% (Study 2)

702

(T=353

C=349)
NA Clinical No Microtubule Inhibitor
CEMIPLIMAB-RWLC BLA761097 Locally advanced basal cell carcinoma Efficacy 2021-02-09 BCC Objective Response Rate RR: 29%

112

(laBCC=84)
20 Composite No PD-1 Targeted Antibody
CEMIPLIMAB-RWLC BLA761097 Metastatic basal cell carcinoma Efficacy 2021-02-09 BCC Objective Response Rate RR: 21%

112

(mBCC=28)
NA Composite Yes PD-1 Targeted Antibody
Table 1. Therapies with Indications for Skin Cancer
The above table lists the therapeutic agents (or agents) that were the subject of the submitted application. Key data, such as the NDA/BLA number, submission class, action date, disease for which the labeled indication is directed (“Skin Neoplasia”), the primary endpoint of the pivotal trial, the major efficacy outcome measure, the number of subjects enrolled in the pivotal trial, the lower bound 95% confidence interval proposed by the sponsor as the minimally effective response rate demonstrative of efficacy, mechanism, trial design, tools used for primary endpoint assessment, approval pathway, and action number in regard to skin cancer actions are listed. “Non-placebo comparator” connotes either an active comparator (e.g., an alternate standard of care therapy) or multiple dose levels of the investigational agent. The number of Subjects Enrolled for the specific submission are provided along with a parenthetical notation of relevant treatment groups in the study. For example, submissions with comparator groups are listed with the convention T=x and C=x to connote the number of subjects in the “treatment” and “control/comparator” groups, respectively. Additional clarifications are provided in the parentheticals in this column. For example, the approvals for the 02-09-2021 supplement for cemiplimab-RWLC and the 05-14-2020 supplement of pomalidomide are reported on individual rows in the table for the distinct labeled indications (e.g. laBCC/mBCC and HIV-negative/HIV-positive KS, respectively) to highlight the differences in indication. However, the number of subjects listed in the column “Subjects Enrolled” represents the total number of subjects evaluated for that submission to reflect the totality of evidence for which the approvals were made, with the number of subjects with that specific disease subgroup appearing in the parenthetical. Abbreviations. AEs: adverse events, AK: actinic keratosis, BCC: basal cell carcinoma, Bin/Enc: binimetinib/encorafenib, C: comparator/control, CCR: complete clearance rate, CI: confidence interval, CTCL: cutaneous T-cell lymphoma, DFSP: dermatofibrosarcoma protuberans, DoR: duration of response, D: dabrafenib, DP: dabrafenib/placebo, DT: dabrafenib/trametinib, DT1: dabrafenib/trametinib 1mg, DT2: dabrafenib/trametinib 2mg, Enc: encorafenib, GP: gp100, HIV: human immunodeficiency virus, H/N: head and neck, HR: hazard ratio, I: ipilimumab, IGP: ipilimumab plus gp100, IN: ipilimumab/nivolumab, KS: Kaposi’s sarcoma, laBCC: locally advanced basal cell carcinoma, laCSCC: locally advanced cutaneous squamous cell carcinoma, mBCC: metastatic basal cell carcinoma, MCC: Merkel cell carcinoma, mcg: microgram, mut: mutant, N: nivolumab, NA: missing, ORR: objective/overall response rate, OS: overall survival, P2: pembrolizumab 2mg/kg, P10: pembrolizumab 10mg/kg, PFS: progression-free survival, RFS: recurrence-free survival, RR: response rate, T: treatment, T/E: trunk and extremities, Tx: treatment, r/mCSCC: recurrent/metastatic cutaneous squamous cell carcinoma, SCC: squamous cell carcinoma, wt: wild type, Vem: vemurafenib.


Table 2. Label Modifications to Therapeutics with an Indication in Skin Cancer
Substance Name Brand Name Application Number Submission Class Action Date
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 TYPE 1 1949-03-15
CORTISONE ACETATE CORTONE NDA007110 TYPE 1 1950-06-13
CORTISONE ACETATE CORTONE NDA007750 TYPE 3 1950-12-04
HYDROCORTISONE CORTEF NDA008697 TYPE 5 1952-12-15
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 TYPE 1 1953-12-07
METHOXSALEN 8-MOP NDA009048 TYPE 1 1954-12-03
PREDNISONE METICORTEN NDA009766 TYPE 1 1955-02-21
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 TYPE 2 1955-04-27
PREDNISOLONE DELTA-CORTEF NDA009987 TYPE 1 1955-06-21
METHYLPREDNISOLONE MEDROL NDA011153 TYPE 1 1957-10-24
TRIAMCINOLONE ARISTOCORT NDA011161 TYPE 1 1957-12-03
DEXAMETHASONE DECADRON NDA011664 TYPE 1 1958-10-30
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 TYPE 2 1959-03-12
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 TYPE 2 1959-05-18
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 TYPE 2 1959-05-27
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 TYPE 2 1959-08-10
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 TYPE 3 1959-10-06
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 TYPE 2 1959-11-16
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 TYPE 1 1959-11-16
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 TYPE 3 1960-06-21
DEXAMETHASONE DECADRON NDA012376 TYPE 3 1960-07-07
BETAMETHASONE CELESTONE NDA012657 TYPE 1 1961-04-17
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 TYPE 5 1961-09-05
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 TYPE 5 1965-02-01
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 TYPE 1 1965-03-03
VINBLASTINE SULFATE VELBAN NDA012665 TYPE 1 1965-11-25
VINBLASTINE SULFATE VELBAN NDA012665 TYPE 1 1965-11-25
HYDROXYUREA DROXIA NDA016295 TYPE 1 1967-12-07
FLUOROURACIL EFUDEX NDA016831 TYPE 3 1970-07-29
FLUOROURACIL FLUOROPLEX NDA016988 TYPE 5 1971-08-06
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 TYPE 1 1974-08-07
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1974-09-19
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1974-11-13
METHOXSALEN 8-MOP NDA009048 S 1974-11-13
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1974-12-17
METHOXSALEN 8-MOP NDA009048 LABELING 1975-04-04
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1975-05-05
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1975-05-07
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1975-05-07
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1975-05-12
DACARBAZINE DTIC-DOME NDA017575 TYPE 1 1975-05-27
FLUOROURACIL EFUDEX NDA016831 EFFICACY 1975-06-30
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1975-07-22
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1975-08-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1975-10-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1975-11-03
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1975-11-03
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1975-11-10
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1975-11-25
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1975-12-05
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1975-12-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1976-01-13
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 S 1976-01-26
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 LABELING 1976-02-27
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1976-03-25
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1976-06-09
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1976-06-09
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1976-06-10
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-06-29
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1976-06-29
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-06-29
FLUOROURACIL FLUOROPLEX NDA016988 LABELING 1976-07-09
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-08-03
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1976-08-06
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-09-07
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-09-07
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-09-07
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1976-09-10
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1976-09-14
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-09-14
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1976-09-14
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 REMS 1976-10-18
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1976-10-18
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1976-11-01
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1976-11-01
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1976-12-21
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1977-01-13
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1977-03-02
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1977-03-17
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1977-03-17
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1977-03-18
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-03-22
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-03-22
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1977-03-28
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-03-29
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1977-04-20
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1977-04-25
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1977-04-26
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1977-04-26
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1977-04-29
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1977-04-29
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1977-05-03
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1977-05-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1977-07-14
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-07-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-07-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1977-07-25
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1977-08-02
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1977-08-10
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1977-08-18
FLUOROURACIL FLUOROPLEX NDA016988 LABELING 1977-09-01
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 MANUF (CMC) 1977-11-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1977-11-16
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1977-11-16
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1977-12-14
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1977-12-14
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1978-01-09
PREDNISONE METICORTEN NDA009766 LABELING 1978-01-25
HYDROCORTISONE CORTEF NDA008697 LABELING 1978-02-08
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 1978-04-07
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1978-04-07
METHYLPREDNISOLONE MEDROL NDA011153 LABELING 1978-04-11
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1978-04-17
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1978-05-23
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 1978-06-12
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1978-07-03
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1978-07-10
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1978-07-12
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1978-07-19
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1978-08-08
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1978-08-08
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 S 1978-08-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1978-08-22
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1978-08-28
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1978-08-29
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1978-09-13
PREDNISOLONE DELTA-CORTEF NDA009987 LABELING 1978-09-25
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1978-09-25
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1978-10-11
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 LABELING 1978-10-18
BETAMETHASONE CELESTONE NDA012657 LABELING 1978-11-08
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1978-11-21
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1978-11-27
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1978-11-28
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1978-12-07
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1978-12-13
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1978-12-14
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1979-01-02
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1979-01-10
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1979-02-15
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1979-02-16
PREDNISONE METICORTEN NDA009766 S 1979-02-26
DEXAMETHASONE DECADRON NDA012376 MANUF (CMC) 1979-03-01
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1979-03-14
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1979-04-05
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1979-04-05
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1979-04-30
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1979-05-01
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1979-05-24
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1979-05-24
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1979-05-30
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1979-06-18
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1979-06-19
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1979-07-17
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1979-07-23
DEXAMETHASONE DECADRON NDA011664 LABELING 1979-07-26
DEXAMETHASONE DECADRON NDA011664 LABELING 1979-07-26
DEXAMETHASONE DECADRON NDA011664 LABELING 1979-07-26
DEXAMETHASONE DECADRON NDA011664 LABELING 1979-07-26
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 1979-07-27
CORTISONE ACETATE CORTONE NDA007750 LABELING 1979-08-01
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1979-08-03
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1979-08-03
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1979-08-06
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 1979-08-08
CORTISONE ACETATE CORTONE NDA007110 LABELING 1979-08-15
DEXAMETHASONE DECADRON NDA011664 LABELING 1979-08-15
DEXAMETHASONE DECADRON NDA012376 LABELING 1979-08-15
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 LABELING 1979-08-15
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1979-08-21
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1979-09-05
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1979-09-24
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1979-09-24
CORTISONE ACETATE CORTONE NDA007750 LABELING 1979-09-25
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1979-10-03
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1979-10-15
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1979-10-23
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1979-10-26
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1979-10-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1979-10-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1979-10-31
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 1979-11-13
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1979-12-03
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1979-12-18
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1980-01-25
CORTISONE ACETATE CORTONE NDA007750 LABELING 1980-02-01
DEXAMETHASONE DECADRON NDA011664 LABELING 1980-02-04
DEXAMETHASONE DECADRON NDA011664 LABELING 1980-02-04
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1980-02-05
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1980-02-19
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 1980-02-19
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 LABELING 1980-02-29
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1980-02-29
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1980-03-31
METHYLPREDNISOLONE MEDROL NDA011153 LABELING 1980-04-14
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 1980-04-14
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1980-04-23
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1980-04-28
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1980-05-20
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1980-06-11
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1980-06-20
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1980-07-07
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1980-07-29
PREDNISONE METICORTEN NDA009766 MANUF (CMC) 1980-08-27
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1980-09-18
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1980-09-27
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1980-09-27
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1980-09-30
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1980-10-03
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1980-10-06
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1980-10-08
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1980-10-27
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1980-12-03
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1981-01-12
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1981-02-05
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1981-02-17
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 1981-02-20
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1981-02-27
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1981-03-21
DEXAMETHASONE DECADRON NDA011664 LABELING 1981-04-01
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1981-04-11
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1981-04-27
DACARBAZINE DTIC-DOME NDA017575 EFFICACY 1981-04-29
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1981-05-11
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1981-07-02
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1981-07-28
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1981-08-11
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1981-10-13
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1981-10-16
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1981-11-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1981-12-07
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1981-12-11
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1981-12-15
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 1981-12-15
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 MANUF (CMC) 1981-12-28
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1982-02-10
DEXAMETHASONE DECADRON NDA012376 MANUF (CMC) 1982-02-10
CORTISONE ACETATE CORTONE NDA007750 MANUF (CMC) 1982-03-02
CORTISONE ACETATE CORTONE NDA007110 MANUF (CMC) 1982-03-04
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1982-03-04
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1982-03-04
FLUOROURACIL EFUDEX NDA016831 LABELING 1982-03-10
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1982-03-15
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1982-03-15
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1982-03-31
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1982-03-31
METHYLPREDNISOLONE ACETATE MEDROL ACETATE NDA012421 LABELING 1982-04-02
METHOXSALEN 8-MOP NDA009048 LABELING 1982-05-07
METHOXSALEN 8-MOP NDA009048 LABELING 1982-05-07
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1982-05-14
DEXAMETHASONE DECADRON NDA012376 LABELING 1982-05-21
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1982-06-11
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1982-06-30
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1982-06-30
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1982-06-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1982-07-28
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1982-07-28
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1982-07-30
DEXAMETHASONE DECADRON NDA011664 LABELING 1982-07-30
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1982-08-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1982-08-30
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1982-11-04
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1982-11-23
CORTISONE ACETATE CORTONE NDA007110 MANUF (CMC) 1982-12-09
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1983-02-04
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1983-02-21
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1983-02-24
HYDROCORTISONE CORTEF NDA008697 MANUF (CMC) 1983-03-09
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1983-03-09
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1983-03-09
METHYLPREDNISOLONE MEDROL NDA011153 LABELING 1983-03-09
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1983-03-14
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1983-03-15
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1983-03-15
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1983-03-22
DACARBAZINE DTIC-DOME NDA017575 LABELING 1983-04-05
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1983-04-08
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1983-04-08
METHOXSALEN 8-MOP NDA009048 LABELING 1983-04-21
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1983-04-26
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 1983-05-03
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1983-05-11
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1983-08-04
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1983-08-10
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1983-08-12
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1983-08-12
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1983-08-25
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-01-04
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1984-04-04
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1984-04-05
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1984-04-13
METHOXSALEN 8-MOP NDA009048 LABELING 1984-04-16
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1984-05-03
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1984-05-04
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-05-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-06-14
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1984-06-14
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-06-15
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1984-06-25
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-07-18
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1984-07-19
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1984-08-10
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1984-08-13
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-08-20
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1984-10-17
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1984-12-10
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1985-01-16
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1985-02-27
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1985-03-04
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 LABELING 1985-03-08
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1985-03-14
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1985-03-28
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1985-05-02
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1985-05-06
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1985-05-20
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1985-06-07
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1985-06-10
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 1985-06-14
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1985-06-18
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1985-07-15
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1985-07-16
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 1985-07-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1985-08-06
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1985-08-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1985-08-30
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1985-08-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1985-09-24
DEXAMETHASONE DECADRON NDA011664 LABELING 1985-11-26
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1985-12-04
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1985-12-04
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1985-12-05
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1985-12-05
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1985-12-10
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1986-01-15
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1986-01-15
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1986-01-23
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1986-01-31
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1986-02-11
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-02-14
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1986-02-14
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1986-03-21
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 1986-03-29
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1986-05-12
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1986-05-12
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1986-05-12
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1986-05-21
DACARBAZINE DTIC-DOME NDA017575 LABELING 1986-05-22
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 TYPE 3 1986-05-28
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-05-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-05-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-05-30
INTERFERON ALFA-2B INTRON A BLA103132 TYPE 1 1986-06-04
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1986-06-10
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1986-06-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1986-07-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1986-07-11
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1986-08-14
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1986-09-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1986-09-16
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1986-09-16
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1986-09-25
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1986-10-20
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1986-11-03
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1986-11-06
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1986-11-14
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1986-11-19
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1986-11-29
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-12-08
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1986-12-08
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1986-12-08
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1986-12-08
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1986-12-08
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1986-12-08
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1987-01-07
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 1987-01-15
FLUOROURACIL FLUOROPLEX NDA016988 LABELING 1987-01-28
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1987-02-19
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1987-02-24
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1987-03-19
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1987-03-19
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1987-03-19
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1987-03-19
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1987-03-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1987-03-25
FLUOROURACIL EFUDEX NDA016831 LABELING 1987-03-26
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1987-03-27
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1987-04-02
PREDNISONE METICORTEN NDA009766 MANUF (CMC) 1987-04-02
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1987-04-28
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 EFFICACY 1987-04-29
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1987-04-29
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1987-04-29
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 EFFICACY 1987-04-29
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1987-04-29
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1987-04-29
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1987-05-05
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1987-07-01
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1987-07-02
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1987-07-22
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1987-07-22
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1987-07-23
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1987-08-18
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1987-08-25
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 1987-09-18
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1987-10-16
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1987-11-20
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1987-11-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1987-12-30
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1988-01-11
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1988-01-12
METHOXSALEN 8-MOP NDA009048 EFFICACY 1988-03-23
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1988-03-25
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 EFFICACY 1988-04-07
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1988-04-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1988-04-18
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1988-04-21
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1988-04-28
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1988-05-03
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1988-05-10
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1988-05-13
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1988-08-25
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1988-10-31
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 EFFICACY 1988-10-31
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1988-10-31
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1988-11-21
INTERFERON ALFA-2A ROFERON BLA103145 EFFICACY 1988-11-21
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1988-11-30
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1988-12-02
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1989-01-05
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1989-01-05
DEXAMETHASONE DECADRON NDA012376 MANUF (CMC) 1989-01-12
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1989-02-02
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1989-03-01
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1989-03-01
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 1989-03-22
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 1989-03-22
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1989-04-19
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1989-04-24
CORTISONE ACETATE CORTONE NDA007750 LABELING 1989-05-16
CORTISONE ACETATE CORTONE NDA007110 LABELING 1989-05-16
DEXAMETHASONE DECADRON NDA011664 LABELING 1989-05-16
DEXAMETHASONE DECADRON NDA012376 LABELING 1989-05-16
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1989-05-18
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1989-06-06
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1989-06-06
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1989-07-11
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1989-10-02
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1989-10-12
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1989-10-12
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1989-10-27
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1989-11-16
CORTISONE ACETATE CORTONE NDA007750 MANUF (CMC) 1989-11-30
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1989-12-11
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 1989-12-14
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1990-01-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1990-01-18
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1990-01-18
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1990-03-29
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1990-04-24
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1990-05-01
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1990-06-18
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1990-08-10
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1990-10-05
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 1990-10-22
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1990-10-24
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1990-10-24
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1990-11-15
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1990-12-07
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1991-02-20
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1991-04-01
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1991-07-19
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1991-07-24
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1991-07-29
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 1991-09-04
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1991-11-05
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1992-01-06
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1992-01-22
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1992-01-23
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1992-02-06
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1992-02-06
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1992-02-06
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1992-02-06
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1992-02-14
ALDESLEUKIN PROLEUKIN BLA103293 TYPE 1 1992-05-05
PREDNISONE METICORTEN NDA009766 LABELING 1992-07-06
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1992-07-13
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1992-07-31
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1992-07-31
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1992-11-05
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1992-11-05
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1992-12-08
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1992-12-16
BETAMETHASONE CELESTONE NDA012657 LABELING 1992-12-17
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 1992-12-17
PREDNISONE METICORTEN NDA009766 LABELING 1992-12-17
PACLITAXEL TAXOL NDA020262 TYPE 1 1992-12-29
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1993-01-28
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1993-03-04
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1993-03-09
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1993-05-14
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1993-06-25
PACLITAXEL TAXOL NDA020262 LABELING 1993-07-23
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1993-08-05
DEXAMETHASONE DECADRON NDA011664 LABELING 1993-08-25
CORTISONE ACETATE CORTONE NDA007110 LABELING 1993-08-26
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 LABELING 1993-08-26
CORTISONE ACETATE CORTONE NDA007750 LABELING 1993-08-27
DEXAMETHASONE DECADRON NDA012376 LABELING 1993-08-27
TRIAMCINOLONE ARISTOCORT NDA011161 LABELING 1993-09-07
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 LABELING 1993-09-07
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 LABELING 1993-09-07
BETAMETHASONE CELESTONE NDA012657 LABELING 1993-09-07
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 1993-09-07
PREDNISONE METICORTEN NDA009766 LABELING 1993-09-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1993-09-07
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1993-11-05
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1993-11-08
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 1993-11-22
HYDROCORTISONE CORTEF NDA008697 MANUF (CMC) 1993-12-08
HYDROCORTISONE CORTEF NDA008697 LABELING 1993-12-28
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1993-12-28
METHYLPREDNISOLONE MEDROL NDA011153 LABELING 1993-12-28
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 1993-12-28
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1994-01-07
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1994-03-14
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1994-03-16
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1994-03-25
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1994-03-25
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1994-03-28
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1994-03-30
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1994-04-06
BETAMETHASONE CELESTONE NDA012657 LABELING 1994-04-13
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 1994-04-13
PREDNISONE METICORTEN NDA009766 LABELING 1994-04-13
PACLITAXEL TAXOL NDA020262 EFFICACY 1994-04-13
CORTISONE ACETATE CORTONE NDA007110 MANUF (CMC) 1994-04-20
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1994-04-21
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1994-04-22
PACLITAXEL TAXOL NDA020262 EFFICACY 1994-06-22
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1994-07-22
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1994-08-04
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1994-08-04
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1994-08-10
CORTISONE ACETATE CORTONE NDA007750 MANUF (CMC) 1994-08-18
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1994-09-15
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1994-09-15
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1994-10-18
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1994-10-19
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1994-10-20
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1994-11-29
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1994-12-06
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1995-01-10
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1995-01-12
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 1995-01-24
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1995-02-15
FLUOROURACIL EFUDEX NDA016831 LABELING 1995-03-21
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1995-03-22
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1995-04-10
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1995-04-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1995-04-26
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1995-05-03
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1995-05-05
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1995-05-10
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1995-07-05
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1995-09-05
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1995-11-06
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1995-11-09
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1995-11-09
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 TYPE 3 1995-11-17
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1995-12-05
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1995-12-13
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1995-12-20
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1995-12-20
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 1996-01-25
CORTISONE ACETATE CORTONE NDA007750 MANUF (CMC) 1996-03-01
CORTISONE ACETATE CORTONE NDA007110 MANUF (CMC) 1996-03-01
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1996-03-01
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1996-03-01
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 1996-03-08
PACLITAXEL TAXOL NDA020262 LABELING 1996-04-01
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1996-04-03
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 TYPE 3 1996-04-08
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1996-05-03
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 1996-05-22
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1996-05-24
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 1996-07-10
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1996-08-27
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1996-09-10
HYDROXYUREA DROXIA NDA016295 LABELING 1996-09-24
HYDROXYUREA DROXIA NDA016295 LABELING 1996-09-24
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1996-10-11
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1996-10-15
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1996-10-21
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1996-11-07
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1996-11-13
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1996-11-25
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1996-12-13
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 1996-12-20
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1997-02-18
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1997-02-24
IMIQUIMOD ALDARA NDA020723 TYPE 1 1997-02-27
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1997-03-05
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1997-03-11
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1997-03-26
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1997-04-07
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1997-04-25
INTERFERON ALFA-2B INTRON A BLA103132 S 1997-04-29
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1997-05-07
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1997-05-20
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1997-05-20
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1997-05-23
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 1997-05-29
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1997-06-30
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1997-07-21
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 1997-07-31
PACLITAXEL TAXOL NDA020262 EFFICACY 1997-08-04
PREDNISONE METICORTEN NDA009766 MANUF (CMC) 1997-08-26
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1997-09-02
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1997-09-09
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1997-09-18
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 1997-09-23
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 1997-09-23
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 1997-10-14
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1997-10-22
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1997-11-06
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 1997-11-07
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 1997-12-08
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1997-12-19
ALDESLEUKIN PROLEUKIN BLA103293 EFFICACY 1998-01-09
ALDESLEUKIN PROLEUKIN BLA103293 EFFICACY 1998-01-09
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 1998-01-21
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1998-02-13
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 1998-02-20
HYDROXYUREA DROXIA NDA016295 EFFICACY 1998-02-25
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1998-02-25
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1998-02-26
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1998-02-26
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1998-02-26
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1998-02-26
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1998-03-16
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 1998-03-16
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 1998-03-31
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1998-04-01
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 1998-04-07
PACLITAXEL TAXOL NDA020262 EFFICACY 1998-04-09
PACLITAXEL TAXOL NDA020262 LABELING 1998-04-09
PACLITAXEL TAXOL NDA020262 LABELING 1998-04-09
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1998-05-14
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 1998-06-18
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1998-06-22
PACLITAXEL TAXOL NDA020262 EFFICACY 1998-06-30
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 1998-08-18
DACARBAZINE DTIC-DOME NDA017575 MANUF (CMC) 1998-09-24
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1998-10-16
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 1998-10-16
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 1998-11-02
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1998-11-05
HYDROXYUREA DROXIA NDA016295 MANUF (CMC) 1998-11-10
BETAMETHASONE CELESTONE NDA012657 MANUF (CMC) 1998-11-19
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1998-11-30
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 1998-12-01
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 1998-12-17
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 1998-12-17
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 1998-12-17
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 EFFICACY 1998-12-17
PACLITAXEL TAXOL NDA020262 LABELING 1999-01-08
PACLITAXEL TAXOL NDA020262 LABELING 1999-01-08
PACLITAXEL TAXOL NDA020262 LABELING 1999-01-08
PACLITAXEL TAXOL NDA020262 LABELING 1999-01-08
ALITRETINOIN PANRETIN NDA020886 TYPE 1 1999-02-02
DENILEUKIN DIFTITOX ONTAK BLA103767 TYPE 1 1999-02-05
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 1999-02-12
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 1999-02-17
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 1999-02-19
METHOXSALEN UVADEX NDA020969 TYPE 3 1999-02-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 1999-03-04
VINBLASTINE SULFATE VELBAN NDA012665 MANUF (CMC) 1999-03-04
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 1999-03-16
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 1999-03-19
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1999-03-23
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 1999-05-28
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 1999-05-28
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 1999-06-28
ALITRETINOIN PANRETIN NDA020886 MANUF (CMC) 1999-07-12
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1999-07-15
HYDROXYUREA DROXIA NDA016295 LABELING 1999-08-11
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 1999-08-20
TRIAMCINOLONE ARISTOCORT NDA011161 MANUF (CMC) 1999-09-17
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 1999-10-08
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 1999-10-25
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 1999-10-25
PACLITAXEL TAXOL NDA020262 EFFICACY 1999-10-25
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 1999-10-28
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 1999-10-29
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 1999-10-29
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 1999-11-25
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 1999-12-01
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 TYPE 1 1999-12-03
PACLITAXEL TAXOL NDA020262 LABELING 1999-12-10
BEXAROTENE TARGRETIN NDA021055 TYPE 1 1999-12-29
HYDROXYUREA DROXIA NDA016295 LABELING 2000-01-12
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 2000-02-09
DEXAMETHASONE SODIUM PHOSPHATE DECADRON NDA012071 MANUF (CMC) 2000-02-18
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2000-03-07
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2000-03-07
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 2000-03-15
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 2000-03-28
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2000-03-30
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2000-04-03
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 2000-04-04
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2000-04-04
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2000-04-05
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 2000-04-05
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 2000-04-10
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 2000-05-23
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2000-06-13
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 2000-06-15
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 2000-06-15
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2000-06-20
PACLITAXEL TAXOL NDA020262 EFFICACY 2000-06-20
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2000-06-27
BEXAROTENE TARGRETIN NDA021056 TYPE 3 2000-06-28
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2000-07-07
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2000-07-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2000-08-24
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2000-09-27
DICLOFENAC SODIUM SOLARAZE NDA021005 TYPE 3 2000-10-16
FLUOROURACIL CARAC NDA020985 TYPE 3 2000-10-27
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 2000-11-02
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2000-11-08
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2000-11-08
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 MANUF (CMC) 2000-11-17
ALITRETINOIN PANRETIN NDA020886 MANUF (CMC) 2000-11-21
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 2001-01-05
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 TYPE 1 2001-01-19
FLUOROURACIL CARAC NDA020985 LABELING 2001-01-29
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 2001-01-30
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 2001-01-30
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2001-02-12
BEXAROTENE TARGRETIN NDA021055 MANUF (CMC) 2001-02-14
HYDROXYUREA DROXIA NDA016295 LABELING 2001-02-20
HYDROCORTISONE CORTEF NDA008697 MANUF (CMC) 2001-03-16
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2001-03-28
HYDROXYUREA DROXIA NDA016295 LABELING 2001-04-04
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 2001-04-10
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2001-05-08
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2001-05-08
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 2001-05-23
INTERFERON ALFA-2B INTRON A BLA103132 EFFICACY 2001-06-21
FLUOROURACIL CARAC NDA020985 MANUF (CMC) 2001-07-02
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2001-07-03
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2001-07-03
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 2001-07-24
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 MANUF (CMC) 2001-07-27
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2001-08-07
DICLOFENAC SODIUM SOLARAZE NDA021005 LABELING 2001-08-17
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 MANUF (CMC) 2001-08-29
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 2001-08-29
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2001-08-30
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2001-10-02
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 2001-10-31
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2001-11-29
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2001-11-29
IMIQUIMOD ALDARA NDA020723 LABELING 2001-12-08
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 MANUF (CMC) 2002-01-03
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 2002-01-10
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 2002-01-10
BEXAROTENE TARGRETIN NDA021055 MANUF (CMC) 2002-01-29
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2002-02-01
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 MANUF (CMC) 2002-02-10
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2002-02-19
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2002-02-20
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2002-02-20
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2002-02-20
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2002-02-20
DAUNORUBICIN CITRATE DAUNOXOME NDA050704 LABELING 2002-02-21
PACLITAXEL TAXOL NDA020262 LABELING 2002-03-04
PACLITAXEL TAXOL NDA020262 LABELING 2002-03-04
BEXAROTENE TARGRETIN NDA021056 MANUF (CMC) 2002-03-14
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 2002-04-02
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2002-04-18
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2002-05-20
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 2002-05-22
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 2002-06-18
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2002-06-21
DEXAMETHASONE DECADRON NDA011664 MANUF (CMC) 2002-06-25
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2002-07-17
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2002-08-09
PACLITAXEL TAXOL NDA020262 LABELING 2002-08-29
IMIQUIMOD ALDARA NDA020723 LABELING 2002-09-03
IMIQUIMOD ALDARA NDA020723 LABELING 2002-09-03
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2002-09-25
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2002-09-25
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2002-10-21
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2002-10-21
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 2002-10-25
PREDNISONE METICORTEN NDA009766 LABELING 2002-11-12
PREDNISONE METICORTEN NDA009766 LABELING 2002-11-12
PREDNISONE METICORTEN NDA009766 LABELING 2002-11-12
FLUOROURACIL CARAC NDA020985 MANUF (CMC) 2002-11-15
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2002-11-21
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2002-11-27
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 2002-12-12
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2002-12-13
IMIQUIMOD ALDARA NDA020723 LABELING 2002-12-15
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2002-12-17
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2003-01-03
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 LABELING 2003-01-17
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 LABELING 2003-01-17
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 2003-02-27
PACLITAXEL TAXOL NDA020262 LABELING 2003-03-05
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2003-03-14
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 2003-03-19
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 LABELING 2003-03-26
METHOXSALEN 8-MOP NDA009048 LABELING 2003-03-26
IMATINIB MESYLATE GLEEVEC NDA021588 TYPE 3 2003-04-18
BEXAROTENE TARGRETIN NDA021055 LABELING 2003-04-21
BEXAROTENE TARGRETIN NDA021055 LABELING 2003-04-21
DICLOFENAC SODIUM SOLARAZE NDA021005 LABELING 2003-04-29
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 EFFICACY 2003-05-08
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2003-05-08
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2003-05-20
HYDROXYUREA DROXIA NDA016295 EFFICACY 2003-06-26
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 LABELING 2003-06-27
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 MANUF (CMC) 2003-07-11
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2003-07-29
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2003-10-24
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 2003-10-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 2003-11-07
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2003-11-26
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2003-12-08
FLUOROURACIL CARAC NDA020985 LABELING 2003-12-16
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2004-01-27
MECHLORETHAMINE HYDROCHLORIDE MUSTARGEN NDA006695 LABELING 2004-02-09
HYDROXYUREA DROXIA NDA016295 LABELING 2004-02-19
IMIQUIMOD ALDARA NDA020723 EFFICACY 2004-03-02
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2004-03-05
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2004-03-18
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2004-04-27
DEXAMETHASONE DECADRON NDA011664 LABELING 2004-05-17
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2004-06-23
FLUOROURACIL EFUDEX NDA016831 LABELING 2004-06-24
IMIQUIMOD ALDARA NDA020723 EFFICACY 2004-07-14
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2004-07-23
METHYL AMINOLEVULINATE HYDROCHLORIDE METVIXIA NDA021415 TYPE 3 2004-07-27
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2004-09-23
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2004-10-01
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2004-10-15
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2004-10-15
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 2004-10-27
INTERFERON ALFA-2B INTRON A BLA103132 S 2004-10-27
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 2004-12-03
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 2004-12-15
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 2005-01-28
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2005-03-14
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 2005-04-13
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2005-05-04
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2005-05-18
IMATINIB MESYLATE GLEEVEC NDA021588 MANUF (CMC) 2005-05-19
METHYL AMINOLEVULINATE HYDROCHLORIDE METVIXIA NDA021415 LABELING 2005-05-31
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2005-07-22
IMIQUIMOD ALDARA NDA020723 LABELING 2005-08-09
FLUOROURACIL EFUDEX NDA016831 LABELING 2005-10-13
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2005-10-20
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2005-11-03
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2006-05-10
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2006-05-31
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2006-05-31
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 TYPE 3 2006-06-01
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2006-07-12
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2006-07-28
HYDROXYUREA DROXIA NDA016295 LABELING 2006-09-19
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-09-27
VORINOSTAT ZOLINZA NDA021991 TYPE 1 2006-10-06
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2006-10-10
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-10-19
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-10-19
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-10-19
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-10-19
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2006-10-19
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2006-10-30
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2006-11-20
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2006-12-22
IMIQUIMOD ALDARA NDA020723 EFFICACY 2007-03-22
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 2007-05-17
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 2007-05-17
INTERFERON ALFA-2B INTRON A BLA103132 S 2007-05-22
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2007-05-22
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2007-05-31
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2007-06-01
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2007-07-13
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2007-09-13
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
VINBLASTINE SULFATE VELBAN NDA012665 LABELING 2007-12-07
PREDNISOLONE ACETATE FLO-PRED NDA022067 TYPE 3 2008-01-17
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2008-03-26
IMATINIB MESYLATE GLEEVEC NDA021588 MANUF (CMC) 2008-04-30
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2008-05-02
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 2008-06-10
TRIAMCINOLONE ACETONIDE TRIVARIS NDA022220 TYPE 3 2008-06-16
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2008-06-24
METHYL AMINOLEVULINATE HYDROCHLORIDE METVIXIA NDA021415 EFFICACY 2008-06-26
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2008-06-27
VORINOSTAT ZOLINZA NDA021991 LABELING 2008-07-22
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2008-09-26
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2008-09-26
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2008-09-26
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2008-10-03
DENILEUKIN DIFTITOX ONTAK BLA103767 EFFICACY 2008-10-15
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2008-12-11
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 S 2008-12-11
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2008-12-19
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2009-02-10
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2009-03-10
TRIAMCINOLONE ARISTOCORT NDA011161 LABELING 2009-03-13
TRIAMCINOLONE ARISTOCORT NDA011161 LABELING 2009-03-13
TRIAMCINOLONE ARISTOCORT NDA011161 LABELING 2009-03-13
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2009-04-07
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2009-04-07
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2009-04-08
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 MANUF (CMC) 2009-04-27
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2009-05-08
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2009-05-08
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2009-05-27
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2009-05-27
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 LABELING 2009-07-17
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2009-08-07
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2009-08-07
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2009-09-01
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2009-09-01
VORINOSTAT ZOLINZA NDA021991 EFFICACY 2009-09-23
ROMIDEPSIN ISTODAX NDA022393 TYPE 1 2009-11-05
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 LABELING 2010-01-14
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2010-01-26
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2010-01-28
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2010-02-16
DENILEUKIN DIFTITOX ONTAK BLA103767 LABELING 2010-03-05
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 EFFICACY 2010-03-12
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2010-03-17
IMIQUIMOD ZYCLARA NDA022483 TYPE 5 2010-03-25
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2010-05-06
HYDROXYUREA DROXIA NDA016295 LABELING 2010-05-07
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2010-06-16
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2010-06-24
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2010-07-06
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2010-07-21
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2010-07-21
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 LABELING 2010-07-28
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2010-07-30
PACLITAXEL TAXOL NDA020262 LABELING 2010-08-13
IMIQUIMOD ALDARA NDA020723 LABELING 2010-10-14
INTERFERON ALFA-2B INTRON A BLA103132 S 2011-02-01
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-02-01
IMIQUIMOD ZYCLARA NDA022483 EFFICACY 2011-03-24
IPILIMUMAB YERVOY BLA125377 TYPE 1 2011-03-25
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2011-03-29
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2011-04-01
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2011-04-01
BEXAROTENE TARGRETIN NDA021056 LABELING 2011-04-08
ROMIDEPSIN ISTODAX NDA022393 LABELING 2011-04-12
PACLITAXEL TAXOL NDA020262 LABELING 2011-05-02
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-05-06
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2011-05-13
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-05-13
BEXAROTENE TARGRETIN NDA021055 LABELING 2011-05-16
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2011-06-06
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-06-06
VORINOSTAT ZOLINZA NDA021991 LABELING 2011-06-10
PREDNISOLONE ACETATE FLO-PRED NDA022067 LABELING 2011-06-14
ROMIDEPSIN ISTODAX NDA022393 EFFICACY 2011-06-16
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2011-06-16
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2011-07-15
IMIQUIMOD ZYCLARA NDA022483 EFFICACY 2011-07-15
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2011-07-19
IPILIMUMAB YERVOY BLA125377 LABELING 2011-07-28
VEMURAFENIB ZELBORAF NDA202429 TYPE 1 2011-08-17
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 TYPE 1 2011-08-19
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 EFFICACY 2011-08-19
DENILEUKIN DIFTITOX ONTAK BLA103767 S 2011-08-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2011-09-26
IMIQUIMOD ZYCLARA NDA022483 LABELING 2011-09-29
ROMIDEPSIN ISTODAX NDA022393 LABELING 2011-09-30
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2011-10-20
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2011-10-20
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2011-11-01
VORINOSTAT ZOLINZA NDA021991 LABELING 2011-11-14
DICLOFENAC SODIUM SOLARAZE NDA021005 LABELING 2011-12-08
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2011-12-16
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2011-12-20
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-12-22
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2011-12-22
BEXAROTENE TARGRETIN NDA021055 LABELING 2012-01-06
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2012-01-13
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2012-01-13
INGENOL MEBUTATE PICATO NDA202833 TYPE 1 2012-01-23
HYDROXYUREA DROXIA NDA016295 LABELING 2012-01-26
HYDROXYUREA DROXIA NDA016295 LABELING 2012-01-26
VISMODEGIB ERIVEDGE NDA203388 TYPE 1 2012-01-30
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2012-01-31
IMIQUIMOD ZYCLARA NDA022483 MANUF (CMC) 2012-02-14
IPILIMUMAB YERVOY BLA125377 LABELING 2012-02-16
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 2012-03-31
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 2012-03-31
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2012-06-04
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2012-06-04
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2012-07-02
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2012-07-30
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 2012-09-19
IPILIMUMAB YERVOY BLA125377 LABELING 2012-10-26
METHYL AMINOLEVULINATE HYDROCHLORIDE METVIXIA NDA021415 LABELING 2012-11-20
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2012-12-26
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 2013-01-09
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2013-01-25
POMALIDOMIDE POMALYST NDA204026 TYPE 1 2013-02-08
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2013-02-21
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 2013-03-13
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 2013-03-22
VORINOSTAT ZOLINZA NDA021991 LABELING 2013-04-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 LABELING 2013-05-07
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 LABELING 2013-05-07
VISMODEGIB ERIVEDGE NDA203388 MANUF (CMC) 2013-05-08
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2013-05-15
IPILIMUMAB YERVOY BLA125377 LABELING 2013-05-22
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 TYPE 1 2013-05-29
DABRAFENIB MESYLATE TAFINLAR NDA202806 TYPE 1 2013-05-29
VISMODEGIB ERIVEDGE NDA203388 MANUF (CMC) 2013-06-03
METHOXSALEN UVADEX NDA020969 MANUF (CMC) 2013-06-05
ROMIDEPSIN ISTODAX NDA022393 LABELING 2013-06-13
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2013-07-02
VEMURAFENIB ZELBORAF NDA202429 LABELING 2013-07-03
VEMURAFENIB ZELBORAF NDA202429 LABELING 2013-07-03
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 2013-07-18
BEXAROTENE TARGRETIN NDA021056 MANUF (CMC) 2013-07-22
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2013-08-19
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 TYPE 5 2013-08-23
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 2013-08-30
ROMIDEPSIN ISTODAX NDA022393 MANUF (CMC) 2013-09-13
METHOXSALEN 8-MOP NDA009048 LABELING 2013-09-20
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2013-09-27
POMALIDOMIDE POMALYST NDA204026 MANUF (CMC) 2013-10-03
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 2013-10-07
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 2013-10-08
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 2013-10-10
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 2013-10-11
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2013-10-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2013-10-31
METHOXSALEN UVADEX NDA020969 LABELING 2013-11-01
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2013-11-08
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 MANUF (CMC) 2013-11-14
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2013-11-15
POMALIDOMIDE POMALYST NDA204026 REMS 2013-11-15
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2013-11-15
ALITRETINOIN PANRETIN NDA020886 MANUF (CMC) 2013-11-22
IPILIMUMAB YERVOY BLA125377 LABELING 2013-12-05
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2013-12-09
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2013-12-12
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2013-12-12
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 EFFICACY 2013-12-18
VISMODEGIB ERIVEDGE NDA203388 MANUF (CMC) 2013-12-19
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2013-12-26
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2014-01-08
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2014-01-09
VEMURAFENIB ZELBORAF NDA202429 LABELING 2014-02-06
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2014-02-28
INGENOL MEBUTATE PICATO NDA202833 LABELING 2014-03-12
POMALIDOMIDE POMALYST NDA204026 LABELING 2014-03-13
VEMURAFENIB ZELBORAF NDA202429 EFFICACY 2014-03-19
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-03-28
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2014-03-28
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2014-04-02
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-04-04
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2014-04-04
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2014-04-14
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 MANUF (CMC) 2014-05-21
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2014-05-22
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 MANUF (CMC) 2014-06-09
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-06-09
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2014-06-09
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-06-24
PACLITAXEL TAXOL NDA020262 MANUF (CMC) 2014-06-27
TRIAMCINOLONE DIACETATE ARISTOCORT NDA011685 LABELING 2014-07-03
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 LABELING 2014-07-03
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2014-07-03
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2014-07-03
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2014-07-03
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2014-07-03
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2014-07-03
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 MANUF (CMC) 2014-07-08
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 LABELING 2014-07-09
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 2014-07-22
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-07-22
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2014-07-22
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-07-31
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2014-08-11
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-08-11
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 MANUF (CMC) 2014-08-13
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-08-14
DABRAFENIB MESYLATE TAFINLAR NDA202806 MANUF (CMC) 2014-08-25
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-08-30
TRIAMCINOLONE DIACETATE ARISTOCORT NDA012802 MANUF (CMC) 2014-09-04
PEMBROLIZUMAB KEYTRUDA BLA125514 TYPE 1 2014-09-04
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2014-09-06
POMALIDOMIDE POMALYST NDA204026 REMS 2014-09-12
VEMURAFENIB ZELBORAF NDA202429 MANUF (CMC) 2014-09-23
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 MANUF (CMC) 2014-09-26
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2014-09-29
PREDNISOLONE ACETATE FLO-PRED NDA022067 MANUF (CMC) 2014-10-03
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-10-09
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 MANUF (CMC) 2014-10-13
VISMODEGIB ERIVEDGE NDA203388 MANUF (CMC) 2014-10-15
ROMIDEPSIN ISTODAX NDA022393 EFFICACY 2014-10-15
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2014-11-17
FLUOROURACIL CARAC NDA020985 MANUF (CMC) 2014-11-20
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2014-11-23
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2014-11-23
IMIQUIMOD ZYCLARA NDA022483 MANUF (CMC) 2014-11-24
VEMURAFENIB ZELBORAF NDA202429 LABELING 2014-11-25
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2014-11-26
BEXAROTENE TARGRETIN NDA021055 MANUF (CMC) 2014-12-02
NIVOLUMAB OPDIVO BLA125554 TYPE 1 2014-12-22
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2015-01-22
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2015-01-30
IMIQUIMOD ALDARA NDA020723 MANUF (CMC) 2015-02-03
INGENOL MEBUTATE PICATO NDA202833 MANUF (CMC) 2015-02-03
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2015-02-04
BEXAROTENE TARGRETIN NDA021056 MANUF (CMC) 2015-02-09
PACLITAXEL TAXOL NDA020262 LABELING 2015-03-03
IPILIMUMAB YERVOY BLA125377 REMS 2015-03-16
IPILIMUMAB YERVOY BLA125377 LABELING 2015-03-19
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2015-03-30
NIVOLUMAB OPDIVO BLA125554 LABELING 2015-04-14
NIVOLUMAB OPDIVO BLA125554 LABELING 2015-04-14
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 EFFICACY 2015-04-16
POMALIDOMIDE POMALYST NDA204026 LABELING 2015-04-23
POMALIDOMIDE POMALYST NDA204026 EFFICACY 2015-04-23
POMALIDOMIDE POMALYST NDA204026 LABELING 2015-04-23
FLUOROURACIL CARAC NDA020985 MANUF (CMC) 2015-04-29
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2015-05-06
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2015-05-06
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2015-05-13
VISMODEGIB ERIVEDGE NDA203388 LABELING 2015-05-21
VISMODEGIB ERIVEDGE NDA203388 LABELING 2015-05-21
VISMODEGIB ERIVEDGE NDA203388 LABELING 2015-05-21
VISMODEGIB ERIVEDGE NDA203388 LABELING 2015-05-21
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2015-05-21
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2015-05-21
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2015-06-19
HYDROXYUREA DROXIA NDA016295 LABELING 2015-07-16
HYDROXYUREA DROXIA NDA016295 LABELING 2015-07-16
SONIDEGIB PHOSPHATE ODOMZO NDA205266 TYPE 1 2015-07-24
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 2015-07-28
BEXAROTENE TARGRETIN NDA021055 EFFICACY 2015-07-29
METHOXSALEN 8-MOP NDA009048 MANUF (CMC) 2015-07-30
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 MANUF (CMC) 2015-08-06
VEMURAFENIB ZELBORAF NDA202429 LABELING 2015-08-11
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 2015-08-14
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 EFFICACY 2015-08-17
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2015-08-17
IPILIMUMAB YERVOY BLA125377 LABELING 2015-08-17
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2015-08-18
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 MANUF (CMC) 2015-09-10
POMALIDOMIDE POMALYST NDA204026 REMS 2015-09-14
BEXAROTENE TARGRETIN NDA021055 MANUF (CMC) 2015-09-14
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2015-09-16
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2015-09-23
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2015-09-30
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2015-10-02
INGENOL MEBUTATE PICATO NDA202833 LABELING 2015-10-06
VORINOSTAT ZOLINZA NDA021991 MANUF (CMC) 2015-10-07
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2015-10-09
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2015-10-09
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 2015-10-26
TALIMOGENE LAHERPAREPVEC IMLYGIC BLA125518 TYPE 1 2015-10-27
POMALIDOMIDE POMALYST NDA204026 REMS 2015-10-27
IPILIMUMAB YERVOY BLA125377 EFFICACY 2015-10-28
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 LABELING 2015-10-29
FLUOROURACIL EFUDEX NDA016831 MANUF (CMC) 2015-11-04
COBIMETINIB FUMARATE COTELLIC NDA206192 TYPE 1 2015-11-10
INGENOL MEBUTATE PICATO NDA202833 EFFICACY 2015-11-19
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2015-11-20
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2015-11-20
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2015-11-20
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2015-11-23
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2015-11-23
POMALIDOMIDE POMALYST NDA204026 REMS 2015-12-01
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 2015-12-02
VORINOSTAT ZOLINZA NDA021991 LABELING 2015-12-17
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2015-12-18
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2015-12-18
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2015-12-28
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 MANUF (CMC) 2016-01-07
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-01-23
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-01-23
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 2016-01-29
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2016-01-29
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 MANUF (CMC) 2016-02-03
SONIDEGIB PHOSPHATE ODOMZO NDA205266 LABELING 2016-02-17
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 MANUF (CMC) 2016-02-25
FLUOROURACIL FLUOROPLEX NDA016988 MANUF (CMC) 2016-03-01
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2016-03-04
HYDROXYUREA DROXIA NDA016295 LABELING 2016-03-23
HYDROXYUREA DROXIA NDA016295 LABELING 2016-03-23
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 MANUF (CMC) 2016-03-29
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 MANUF (CMC) 2016-04-08
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 MANUF (CMC) 2016-04-08
INGENOL MEBUTATE PICATO NDA202833 MANUF (CMC) 2016-04-15
POMALIDOMIDE POMALYST NDA204026 REMS 2016-04-22
DICLOFENAC SODIUM SOLARAZE NDA021005 LABELING 2016-05-09
VEMURAFENIB ZELBORAF NDA202429 LABELING 2016-05-09
AMINOLEVULINIC ACID HYDROCHLORIDE AMELUZ NDA208081 TYPE 3 2016-05-10
SONIDEGIB PHOSPHATE ODOMZO NDA205266 LABELING 2016-05-12
DICLOFENAC SODIUM SOLARAZE NDA021005 MANUF (CMC) 2016-05-16
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-05-17
ATEZOLIZUMAB TECENTRIQ BLA761034 TYPE 1 2016-05-18
COBIMETINIB FUMARATE COTELLIC NDA206192 LABELING 2016-05-31
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2016-06-16
POMALIDOMIDE POMALYST NDA204026 LABELING 2016-06-30
POMALIDOMIDE POMALYST NDA204026 LABELING 2016-06-30
FLUOROURACIL FLUOROPLEX NDA016988 LABELING 2016-07-25
ROMIDEPSIN ISTODAX NDA022393 LABELING 2016-07-27
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 MANUF (CMC) 2016-07-28
DEXAMETHASONE DECADRON NDA011664 LABELING 2016-07-29
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2016-08-05
IMATINIB MESYLATE GLEEVEC NDA021588 EFFICACY 2016-08-25
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2016-08-25
VEMURAFENIB ZELBORAF NDA202429 EFFICACY 2016-08-31
HYDROCORTISONE CORTEF NDA008697 LABELING 2016-09-08
HYDROCORTISONE CORTEF NDA008697 LABELING 2016-09-08
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2016-09-08
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2016-09-08
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2016-09-08
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2016-09-08
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2016-09-08
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-09-13
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-09-13
INGENOL MEBUTATE PICATO NDA202833 LABELING 2016-09-13
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2016-09-27
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2016-09-28
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-10-04
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2016-10-24
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2016-10-24
CYCLOPHOSPHAMIDE CYTOXAN (LYOPHILIZED) NDA012142 MANUF (CMC) 2016-10-31
VISMODEGIB ERIVEDGE NDA203388 LABELING 2016-11-02
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2016-11-10
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 MANUF (CMC) 2016-12-22
INGENOL MEBUTATE PICATO NDA202833 MANUF (CMC) 2017-01-26
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2017-02-02
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 LABELING 2017-02-24
IPILIMUMAB YERVOY BLA125377 LABELING 2017-03-03
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-03-14
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2017-03-15
AVELUMAB BAVENCIO BLA761049 TYPE 1 2017-03-23
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2017-04-17
VEMURAFENIB ZELBORAF NDA202429 LABELING 2017-04-17
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2017-04-24
AVELUMAB BAVENCIO BLA761049 LABELING 2017-04-25
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2017-04-25
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-05-10
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-05-17
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-05-18
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-05-18
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-05-23
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2017-05-25
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2017-06-12
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2017-06-16
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2017-06-22
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2017-06-22
POMALIDOMIDE POMALYST NDA204026 REMS 2017-06-27
IPILIMUMAB YERVOY BLA125377 EFFICACY 2017-07-21
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2017-07-27
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2017-07-27
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2017-07-31
VISMODEGIB ERIVEDGE NDA203388 LABELING 2017-08-01
AMINOLEVULINIC ACID HYDROCHLORIDE AMELUZ NDA208081 LABELING 2017-09-06
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2017-09-06
NIVOLUMAB OPDIVO BLA125554 LABELING 2017-09-06
VEMURAFENIB ZELBORAF NDA202429 EFFICACY 2017-09-13
VEMURAFENIB ZELBORAF NDA202429 LABELING 2017-09-13
SONIDEGIB PHOSPHATE ODOMZO NDA205266 EFFICACY 2017-09-18
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2017-09-22
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2017-09-22
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2017-09-29
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2017-10-02
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2017-10-02
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2017-10-02
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2017-10-03
AVELUMAB BAVENCIO BLA761049 LABELING 2017-10-12
IPILIMUMAB YERVOY BLA125377 EFFICACY 2017-10-20
VEMURAFENIB ZELBORAF NDA202429 EFFICACY 2017-11-06
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 EFFICACY 2017-11-09
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2017-11-29
POMALIDOMIDE POMALYST NDA204026 LABELING 2017-11-30
IPILIMUMAB YERVOY BLA125377 LABELING 2017-12-13
HYDROXYUREA DROXIA NDA016295 LABELING 2017-12-18
HYDROXYUREA DROXIA NDA016295 LABELING 2017-12-18
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2017-12-20
POMALIDOMIDE POMALYST NDA204026 LABELING 2017-12-29
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-01-09
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-01-09
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-01-09
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-01-09
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-01-09
METHOXSALEN UVADEX NDA020969 LABELING 2018-01-09
COBIMETINIB FUMARATE COTELLIC NDA206192 EFFICACY 2018-01-26
PREDNISOLONE SODIUM PHOSPHATE PEDIAPRED NDA019157 LABELING 2018-02-05
IPILIMUMAB YERVOY BLA125377 LABELING 2018-02-08
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2018-02-09
NIVOLUMAB OPDIVO BLA125554 LABELING 2018-02-13
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-02-15
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-02-15
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-03-05
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 EFFICACY 2018-03-06
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 LABELING 2018-03-09
ATEZOLIZUMAB TECENTRIQ BLA761034 LABELING 2018-03-13
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2018-03-15
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 LABELING 2018-03-15
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 EFFICACY 2018-03-20
POMALIDOMIDE POMALYST NDA204026 LABELING 2018-03-20
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2018-03-28
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2018-03-29
BETAMETHASONE ACETATE CELESTONE SOLUSPAN NDA014602 LABELING 2018-04-10
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-04-16
IPILIMUMAB YERVOY BLA125377 EFFICACY 2018-04-16
AMINOLEVULINIC ACID HYDROCHLORIDE LEVULAN NDA020965 LABELING 2018-04-19
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2018-04-20
DEXAMETHASONE DECADRON NDA011664 LABELING 2018-04-23
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2018-04-30
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2018-04-30
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2018-04-30
INTERFERON ALFA-2B INTRON A BLA103132 LABELING 2018-05-04
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2018-05-04
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2018-05-04
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2018-05-04
METHOTREXATE SODIUM METHOTREXATE PRESERVATIVE FREE NDA011719 LABELING 2018-05-07
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2018-05-25
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-06-12
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-06-13
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2018-06-14
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-06-19
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2018-06-19
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 LABELING 2018-06-22
ATEZOLIZUMAB TECENTRIQ BLA761034 LABELING 2018-06-26
ENCORAFENIB BRAFTOVI NDA210496 TYPE 1/4 2018-06-27
BINIMETINIB MEKTOVI NDA210498 TYPE 1/4 2018-06-27
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2018-07-02
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-07-10
IPILIMUMAB YERVOY BLA125377 EFFICACY 2018-07-10
METHYLPREDNISOLONE ACETATE DEPO-MEDROL NDA011757 LABELING 2018-07-24
METHYLPREDNISOLONE MEDROL NDA011153 LABELING 2018-07-24
METHYLPREDNISOLONE SODIUM SUCCINATE SOLU-MEDROL NDA011856 LABELING 2018-07-24
MOGAMULIZUMAB-KPKC POTELIGEO BLA761051 TYPE 1 2018-08-08
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2018-08-16
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-08-16
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-08-20
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2018-08-21
CEMIPLIMAB-RWLC LIBTAYO BLA761097 TYPE 1 2018-09-28
AVELUMAB BAVENCIO BLA761049 EFFICACY 2018-10-19
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-10-30
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-11-09
NIVOLUMAB OPDIVO BLA125554 LABELING 2018-11-15
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 EFFICACY 2018-11-16
ROMIDEPSIN ISTODAX NDA022393 LABELING 2018-11-27
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2018-12-06
VORINOSTAT ZOLINZA NDA021991 LABELING 2018-12-11
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-12-19
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2018-12-21
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2018-12-28
PEGINTERFERON ALFA-2B PEGINTRON BLA103949 LABELING 2019-01-08
VISMODEGIB ERIVEDGE NDA203388 EFFICACY 2019-01-18
CEMIPLIMAB-RWLC LIBTAYO BLA761097 LABELING 2019-01-18
ENCORAFENIB BRAFTOVI NDA210496 EFFICACY 2019-01-23
BINIMETINIB MEKTOVI NDA210498 EFFICACY 2019-01-23
NIVOLUMAB OPDIVO BLA125554 LABELING 2019-02-01
DENILEUKIN DIFTITOX ONTAK BLA103767 LABELING 2019-02-15
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-02-15
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2019-03-07
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2019-03-07
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2019-03-08
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2019-03-18
CEMIPLIMAB-RWLC LIBTAYO BLA761097 LABELING 2019-03-20
VISMODEGIB ERIVEDGE NDA203388 LABELING 2019-03-26
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-04-11
TRIAMCINOLONE ACETONIDE KENALOG-40 NDA014901 MANUF (CMC) 2019-04-12
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2019-04-18
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-04-19
NIVOLUMAB OPDIVO BLA125554 LABELING 2019-05-02
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2019-05-06
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2019-05-06
DEXAMETHASONE DECADRON NDA011664 LABELING 2019-05-08
IPILIMUMAB YERVOY BLA125377 LABELING 2019-05-08
SONIDEGIB PHOSPHATE ODOMZO NDA205266 LABELING 2019-05-13
AVELUMAB BAVENCIO BLA761049 EFFICACY 2019-05-14
ALDESLEUKIN PROLEUKIN BLA103293 LABELING 2019-05-17
ENCORAFENIB BRAFTOVI NDA210496 EFFICACY 2019-05-24
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-06-10
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-06-17
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 LABELING 2019-07-16
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2019-07-16
HYDROXYUREA DROXIA NDA016295 LABELING 2019-07-22
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-07-30
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-07-30
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2019-08-09
DOXORUBICIN HYDROCHLORIDE DOXIL (LIPOSOMAL) NDA050718 LABELING 2019-08-12
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 MANUF (CMC) 2019-08-16
METHYLPREDNISOLONE MEDROL NDA011153 MANUF (CMC) 2019-08-26
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2019-09-17
NIVOLUMAB OPDIVO BLA125554 LABELING 2019-09-18
IPILIMUMAB YERVOY BLA125377 LABELING 2019-09-20
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 EFFICACY 2019-10-06
DABRAFENIB MESYLATE TAFINLAR NDA202806 EFFICACY 2019-10-06
BRENTUXIMAB VEDOTIN ADCETRIS BLA125388 LABELING 2019-10-15
POMALIDOMIDE POMALYST NDA204026 LABELING 2019-10-30
HYDROCORTISONE CORTEF NDA008697 LABELING 2019-11-21
HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF NDA009866 LABELING 2019-11-21
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2019-12-03
HYDROXYUREA DROXIA NDA016295 LABELING 2019-12-18
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2019-12-20
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-01-08
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2020-01-09
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 LABELING 2020-01-13
DENILEUKIN DIFTITOX ONTAK BLA103767 LABELING 2020-02-10
INGENOL MEBUTATE PICATO NDA202833 LABELING 2020-02-13
PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT NDA021959 LABELING 2020-03-06
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-03-10
IPILIMUMAB YERVOY BLA125377 EFFICACY 2020-03-10
ENCORAFENIB BRAFTOVI NDA210496 EFFICACY 2020-04-08
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 LABELING 2020-04-09
DABRAFENIB MESYLATE TAFINLAR NDA202806 LABELING 2020-04-09
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-04-28
MECHLORETHAMINE HYDROCHLORIDE VALCHLOR NDA202317 LABELING 2020-05-01
METHOTREXATE SODIUM METHOTREXATE SODIUM NDA008085 EFFICACY 2020-05-04
POMALIDOMIDE POMALYST NDA204026 EFFICACY 2020-05-14
POMALIDOMIDE POMALYST NDA204026 EFFICACY 2020-05-14
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-05-15
IPILIMUMAB YERVOY BLA125377 EFFICACY 2020-05-15
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-05-18
VEMURAFENIB ZELBORAF NDA202429 LABELING 2020-05-18
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-05-26
IPILIMUMAB YERVOY BLA125377 EFFICACY 2020-05-26
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-05-29
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-06-10
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-06-16
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-06-16
TRAMETINIB DIMETHYL SULFOXIDE MEKINIST NDA204114 LABELING 2020-06-23
NIVOLUMAB OPDIVO BLA125554 LABELING 2020-06-23
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-06-24
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-06-24
CEMIPLIMAB-RWLC LIBTAYO BLA761097 EFFICACY 2020-06-25
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-06-29
IPILIMUMAB YERVOY BLA125377 LABELING 2020-06-29
AVELUMAB BAVENCIO BLA761049 EFFICACY 2020-06-30
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-07-30
VISMODEGIB ERIVEDGE NDA203388 LABELING 2020-07-31
CYCLOPHOSPHAMIDE CYTOXAN NDA012141 MANUF (CMC) 2020-08-07
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2020-08-10
IMATINIB MESYLATE GLEEVEC NDA021588 LABELING 2020-08-10
IPILIMUMAB YERVOY BLA125377 LABELING 2020-08-13
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NDA050467 LABELING 2020-08-28
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-09-18
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-09-18
IPILIMUMAB YERVOY BLA125377 EFFICACY 2020-09-18
NIVOLUMAB OPDIVO BLA125554 LABELING 2020-09-25
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-09-30
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2020-10-02
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-10-02
IPILIMUMAB YERVOY BLA125377 EFFICACY 2020-10-02
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-10-14
AVELUMAB BAVENCIO BLA761049 LABELING 2020-11-10
CEMIPLIMAB-RWLC LIBTAYO BLA761097 LABELING 2020-11-10
NIVOLUMAB OPDIVO BLA125554 LABELING 2020-11-10
PEMBROLIZUMAB KEYTRUDA BLA125514 LABELING 2020-11-10
ATEZOLIZUMAB TECENTRIQ BLA761034 LABELING 2020-11-10
PEMBROLIZUMAB KEYTRUDA BLA125514 EFFICACY 2020-11-13
IPILIMUMAB YERVOY BLA125377 LABELING 2020-11-13
POMALIDOMIDE POMALYST NDA204026 EFFICACY 2020-11-20
POMALIDOMIDE POMALYST NDA204026 LABELING 2020-12-03
TIRBANIBULIN KLISYRI NDA213189 TYPE 1 2020-12-14
INGENOL MEBUTATE PICATO NDA202833 LABELING 2020-12-17
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-12-18
ATEZOLIZUMAB TECENTRIQ BLA761034 EFFICACY 2020-12-18
NIVOLUMAB OPDIVO BLA125554 LABELING 2020-12-29
NIVOLUMAB OPDIVO BLA125554 EFFICACY 2021-01-22
HYDROXYUREA DROXIA NDA016295 LABELING 2021-02-09
CEMIPLIMAB-RWLC LIBTAYO BLA761097 EFFICACY 2021-02-09
CEMIPLIMAB-RWLC LIBTAYO BLA761097 EFFICACY 2021-02-09

Table 2. Label Modifications to Therapeutics with an Indication in Skin Cancer
The above table lists all labeling modifications for the therapeutic agents (or agents) with an indication for skin cancer. Abbreviations - TYPE1: Type 1 - New Molecular Entity; TYPE2: Type 2 - New Active Ingredient; TYPE3 - New Dosage Form; TYPE4: Type 4 - New Combination; TYPE5: Type 5 - New Formulation or New Manufacturer; MANUF (CMC): Chemistry, Manufacturing and Controls.

REFERENCES

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Rogers, H. W., Weinstock, M. A., Feldman, S. R. & Coldiron, B. M. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the u.s. Population, 2012. JAMA Dermatol 151, 1081–6 (2015).
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Avatar
David Michael Miller
Medical Oncologist and Dermatologist

My research interests include clinical and translational research in advanced skin cancers.

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