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Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals

 
• By Derrick Gingery

ANDA approval rates have remained steady, while submission rates dropped compared to prior years.

Generic drugs
The monthly approval rate would be the second-best of the GDUFA era if sustained through the second half of FY 2021. • Source: Alamy

Generic drug submission and full approval rates are nearly equal mid-way through fiscal year 2021, a sign of the steady state the US Food and Drug Administration program is hoping to maintain.

Through March, the FDA reported granting more than 65 full approvals per month, while sponsors submitted about 67 ANDAs per...

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