OGD: Generic Approvals, CRLs Hold Steady As ANDAs Decline

December 20, 2016

Generic approvals and rejections were little changed from last month, remaining stable as ANDAs slightly fell in the second month of fiscal 2017.

The Office of Generic Drugs approved 59 applications in November, up from 54 approvals in the month before. Twelve submissions received tentative approvals, which is only four fewer than those issued in October.

In fiscal 2016, the FDA granted an average of 54 full approvals per month. It issued roughly 15 tentative approvals each month for that fiscal year.

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