Generic Drug Approvals Outpace New Drug Approvals

In 2016, the U.S. Food and Drug Administration (FDA) granted more approvals to generic forms of already-approved drugs than to novel drugs, according to presenters at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting. Last year, the FDA’s Office of Generic Drugs approved 630 abbreviated new drug applications (including a generic version of the leukemia drug imatinib) and tentatively approved another 183.

This is the highest number of generic drug approvals in the history of the FDA’s generic drug program.

There were 41 novel drugs submitted for approval in 2016, with only 22 receiving approval. The FDA’s expedited approval

Last year also saw the lowest number of FDA drug approvals in a single year since 2010, and a drop from 45 drug approvals in 2015.

Source: Kao DJ, “Traditional Brand and Generic Drugs in Development.” Presented at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting, March 28, 2017; Denver, CO.

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