FDA’s Generic Drugs Office Passes Last Year’s Record for ANDAs Received

Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than 330 applications.

For fiscal 2017, the agency has totaled 477 approvals so far, 119 of them tentatively, while issuing 1,124 complete response letters.

The upward trend seems to be slowing, however, as the end of the fiscal year approaches. According to early numbers from the agency’s Office of Generic Drugs, the FDA received just 66 ANDAs in May, continuing a decline from the previous month after a spike of 197 applications in March.