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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.

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