Abbreviated New Drug Application (ANDA): Generics > Office of Generic Drugs (OGD) Annual Report for 2016

Abbreviated New Drug Application (ANDA): Generics > Office of Generic Drugs (OGD) Annual Report for 2016

2016 Annual Report for the Office of Generic Drugs Now Available

2016 at a Glance

• 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.