FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

ANDA Applications Could Hit New Record in Fiscal 2017

April 7, 2017

Fiscal 2017 could be a record-setting year for ANDA applications if trends continue.

Following a wave of ANDAs in December 2016, the number of applications received by the FDA is up by 50 percent over the same point in fiscal 2016 — already matching the total for all of fiscal 2015.

The Office of Generic Drugs logged 57 applications in January and 58 in February. Fiscal 2016 saw 852 applications total, while December 2016 alone brought in 235.

With 539 ANDAs submitted so far in fiscal 2017 — which began Oct. 1, 2016 — compared to 358 by February 2016, fiscal 2017 could set a new record, capping off GDUFA I which expires Sept. 30. The agency received a record high of 1,473 ANDAs in fiscal 2014, but that number dipped to 539 in fiscal 2015.

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