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Pharmaceuticals / Submissions and Approvals

April Sees 66 ANDA Approvals and 112 CRLs

May 15, 2017

The FDA received 75 ANDAs in April, a steep drop from the 197 received in the previous month.

According to early numbers from the agency’s Office of Generic Drugs, 57 applications were approved, plus nine tentatively — slightly lower than March and February’s 62 and 61, respectively.

The agency also issued 112 complete response letters, down from 190. However, these numbers could change as the FDA completes its accounting of refusals-to-receive and ANDA withdrawals, which have not yet been posted.

Halfway through fiscal 2017, the FDA received at least 736 ANDAs — nearly 200 more than for all of fiscal 2015. So far, the agency has totaled 400 approvals, 100 of them tentatively, while accepting 811 ANDAs.

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