Acting FDA Commissioner Ned Sharpless announced that the agency once again approved a record number of generic drugs in fiscal 2019 and flagged upcoming actions to maintain the upward trend.
The agency approved a total of 1,171 generic drugs — 935 full approvals and 236 tentative approvals — in fiscal 2019, breaking the agency’s previous record of 971 in fiscal 2018. Approvals have increased for each fiscal year except for a temporary dip in 2014.
Sharpless said that the agency plans to issue more guidance and host conferences on generic drug development. “We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines,” he said.