Fiscal 2017 Ends With Record High in ANDA Approvals

For fiscal 2017, the FDA approved 763 generic drug applications, beating the previous year’s record of 651 by 17 percent. An additional 174 were granted tentative approval.

In September, the agency approved 70 ANDAs, plus 12 tentatively, according to the Office of Generic Drugs. The FDA also issued 155 complete response letters, holding steady from August. Fiscal 2017’s CRL total of 1,603 dropped slightly, down from 1,725 the year before.

As fiscal 2017 came to a close — and with it, the first generation of the GDUFA program — the FDA saw a spike in the number of ANDAs received. The 202 applications represented the second-highest month, behind December 2016’s 235.