US FDA Generic Approvals Peak In April, But Annual Pace Trends Down

 
• By Derrick Gingery

The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.

FDA approved background, 3D rendering, blue street sign
While approvals may slip from last year's record-breaking tally, ANDA submissions remained on pace to slightly exceed the FY 2019 total, according to data through April. • Source: Shutterstock

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