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 2016’s total of 852 and beating 2015 by more than 330 applications. So far, the agency has totaled 477 approvals for 2017, 119 of them tentatively, and has issued 1,124 complete response letters.
The upward trend seems to be declining, however, after a spike of 197 applications in March.
