2016 Annual Report for the Office of Generic Drugs Now Available
- Approved 630 abbreviated new drug applications (ANDAs) and tentatively approved 183—the highest number of generic drug approvals and tentative approvals in the history of the generic drug program.
- Met required GDUFA review timeframes.
- Published more than 200 product-specific guidances related to developing generic drugs, for a total of more than 1,500 posted on FDA’s website.
- Issued first approvals for generic versions of commonly used drugs including Benicar, Viagra, Crestor, and Tamiflu.
- Awarded funding to 16 new external researchers to conduct regulatory science activities that will complement FDA’s research efforts.
- Supported 87 ongoing external research collaborations.
- Verified validity of FDA’s bioequivalence standards for certain drugs through scientific studies, demonstrating the proven efficacy and safety of generic drugs.
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