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Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

 
• By Derrick Gingery

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

The FDA approved more ANDAs than recent averages in December and January. (Shutterstock)
Key Takeaways
  • Data indicate that full and tentative ANDA approvals were much higher in December than the average over previous months.
  • After seemingly maintaining the pace in January, approvals and tentative approvals appear to have slowed in February.
  • December 2024 data show that submissions increased after two very slow months, but the total was less than the same month in prior years.

Generic drug application approvals pushed through the US Food and Drug Administration at a higher pace in late 2024 and early 2025 than earlier months, but agency data suggest activity...

The Office of Generic Drugs activity report, which compiles a litany of data on generic drug approvals, submissions, amendments and other metrics, has not been updated as frequently as usual...

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