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Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I

 
• By Sue Sutter

Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.

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FDA continues to issue a large number of complete response letters for generic drug applications, and the first-cycle ANDA approval rate could get worse before it gets better as the first generation of the Generic Drug User Fee Act nears expiration, agency officials said.

While agency staff speaking at the Generic Pharmaceutical Association’s Fall Technical Conference Oct. 24 and 25 pointed to positive trends for the regulatory prospects of original ANDAs, they suggested sponsors...

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