FDA approved record number of generic drugs in 2016

The Food and Drug Administration approved a record-high amount of generic drugs last year.

Here are four things to know.

1. The FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research granted more than 800 generic drug approvals in 2016, according to Kathleen Uhl, MD, director of the agency's generic drug office.

2. This figure includes both full and tentative approvals, "which are given to applications ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand name drug," wrote Dr. Uhl in a blog post on the FDA's website.

3. The agency broke its previous record of 726 generic drugs approved in 2015.

4. Dr. Uhl cites the Generic Drug User Fee Amendments of 2012 as a major factor in the agency's record-setting performance. The legislation completely reshaped the FDA's generic drug program by authorizing funds for the agency to hire additional reviewers, modernizing the view of generic drug applications and expanding facility inspection capabilities, among other improvements.

To view the Office of Generic Drug's annual report for 2016, click here.

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