1. Pink Sheet

ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

 
• By Derrick Gingery

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

ANDA submissions dropped dramatically from a 140 in September to 14 in October. (Shutterstock)
Key Takeaways
  • The 14 ANDAs submitted in October were the second-lowest monthly total in the GDUFA era.

The aftermath of an ANDA avalanche hit the US Food and Drug Administration in October, even though the actual crush...

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