USA – FDA on Pace for Record Generic Approvals in 2018

With two months of data outstanding, the US Food and Drug Administration (FDA) is on pace to approve a record number of abbreviated new drug applications (ANDAs) in FY2018.

According to FDA’s latest generic drugs program activity report, the agency has approved 666 ANDAs in the fiscal year through July and has tentatively approved another 162 ANDAs. With an average of 67 ANDA approvals and 16 tentative approvals each month this year, FDA will likely top its record-setting FY2017 performance.

In FY2017, FDA approved or tentatively approved 937 ANDAs, breaking its previous record of 835 in 2016.

FDA’s performance in FY2018 is a promising start to its second Generic Drug User Fee Act (GDUFA II) program and draws a sharp contrast to the conversation around generic drug approvals during the early years of GDUFA I…