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Generic Drug Review: US FDA Approves More ANDAs Than It Receives For First Time Since Early 2016

 
• By Derrick Gingery

Among the 61 approvals in February appear to be ANDAs from the official GDUFA backlog, which have been pending for more than four years.

pills

ANDA approvals outnumbered submissions in February, the first time this has happened at the US FDA in more than a year, and the approval cohort seems to include applications that had been pending for several years.

FDA reported March 8 that it approved 61 ANDAs in February, two more than the 59 ANDAs it received. That...

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