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

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.

Generic drug application approvals pushed through the US Food and Drug Administration at a higher pace in late 2024 and...

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