FDA Breaks Generic Drug Approval Record

FDA announced on Oct. 16, 2019 that the agency approved a total of 1171 generic drugs in fiscal year 2019, which breaks the previous record of 971 in 2018. This number includes 935 full approvals and 236 tentative approvals. The agency also announced it had approved 125 applications for first generics with no generic competition that included treatments for opioid overdose, breast cancer, seizures, and depression. 

The agency has been working to improve its generic-drug approval system as part of the Drug Competition Action Plan and the Generic Drug User Fee Amendments. The agency stated that it is monitoring the safety, effectiveness, and quality of generic drugs and will be inspecting manufacturing plants and carefully evaluating post-approval changes.

“The value of our generic drug program runs deep, and we are engaged in a number of efforts to help ensure the program remains vibrant. We’re encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition. In the coming months, we plan to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers. We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines,” said FDA Acting Commissioner Ned Sharpless, MD, in a statement.

Source: FDA