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ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System

 
• By Derrick Gingery

As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.

Man crushed by Pill

FDA 's generic drug workload increased substantially in December and may provide a stress test of sorts for its enhanced review system and approval pace.

Sponsors submitted 235 abbreviated new drug applications in December, the most received in a single month since the famous June 2014 avalanche when 635 ANDAs arrived. While sponsors tend to push more applications in December than normal to close out their calendar years, the 2016 number is unusually high

December Monthly ANDA Submission Totals
  • 2012: 163
  • 2013: 225
  • 2014: 43
  • 2015:

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