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Pharmaceuticals / Submissions and Approvals

March Sees New Surge of Nearly 200 Submitted ANDAs

April 17, 2017
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The FDA received a fresh wave of ANDAs in March, nearly doubling the total amount from the first two months of the year.

According to early numbers from the agency’s Office of Generic Drugs, the FDA received 197 ANDAs in March, compared to 57 in January and 58 in February.

Meanwhile, OGD issued 62 approvals — steady from the previous month’s 61 — plus 19 tentative approvals, eight more than February.

The agency also issued 190 complete response letters, up from 136. However, these numbers could change as the FDA completes its accounting of refusals-to-receive and ANDA withdrawals, which have not yet been posted.

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