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Generic Application Mystery: Few ANDAs Withdrawn To Start FY 2023

 
• By Derrick Gingery

In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.

generic drugs
US FDA maintained its average ANDA approval pace during the first two months of FY 2023 as was seen in FY 2022. • Source: Shutterstock

Sponsors did not withdraw generic drug applications in large numbers to start fiscal year 2023, a stark change from past years that has some stakeholders wondering why.

No approved and only 12 unapproved ANDAs were withdrawn during October and November 2022, the first two months of the...

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