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U.S. Food and Drug Administration Center for Drug Evaluation and Research

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Approved Oncology Drugs

List of Approved Oncology Drugs with Approved Indications .  The list may be sorted by the drug's generic name, trade name, or manufacturer.  Entries also link to an approval summary, a product label, and a sponsor portfolio [Note: the data are still incomplete].

Index of Oncologic Drugs Advisory Committee Meetings    a useful database to search by meeting date, drug, applicant or indication
Summary Statistics for Oncology Drug Approvals   
What is a Drug Used for?    Covers drugs that have FDA-approved uses; off-label uses of drugs are not included.
What Drugs are Used to Treat a Disease?  Select a specific type of cancer and view approved drugs for that disease.
What are the Pediatric Uses of a Drug?
Fast Track, Priority Review and Accelerated Approval (Subpart H)  What these terms mean and how they are used in the approval process
Access to Unapproved Products.   Several options are presented.

Future Additions

- Decision Making in Cancer Therapy
- The Contribution of Chemotherapy to Cancer Care
- Searchable index of product package inserts (labels) by section and searchable index of clinical trials that were used to support approval

FDA/Center for Drug Evaluation and Research
Last Updated: 
Originator: OTCOM/DLIS