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Generic Companies Race To Withdraw ANDAs

 
• By Derrick Gingery

Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.

Generics
After 606 ANDAs were removed in FY 2018, another 252 have been pulled in FY 2019, many of them approved applications. • Source: Shutterstock

Firms continue to withdraw ANDAs at high rates in fiscal year 2019, offering another look at the changing landscape of the generic industry.

Sponsors had pulled 252 original ANDAs through May, according to the most recent data from the US Food and Drug Administration's generic drug program activity report. Combined with the record...

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