FDA Breaks Record for Most Generic Approvals

The FDA broke its generic drug approval record yet again, FDA Commissioner Scott Gottlieb said, reporting that fiscal 2018 has seen the most approvals and tentative approvals.

The agency granted 971 total approvals in FY 2018, including 781 approvals and 190 tentative approvals, topping FY 2017’s previous record of 937 approvals.

“When I started as FDA Commissioner, I made clear that one of my top priorities would be ensuring the agency does all it can to help ensure American patients have access to affordable, quality medicines that meet their needs,” Gottlieb said. “To accomplish this, we have taken many important actions to encourage the timely development and approval of lower-cost generic drugs and are beginning to see results.”