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Sovaldi NDA Review Marred By Manufacturing Compliance Issues

 
• By Sue Sutter

Faced with the prospects of FDA non-approval of its priority review hepatitis C drug sofosbuvir, Gilead withdrew a foreign API manufacturer and one of its own testing facilities from the NDA late in the review process due to Good Manufacturing Practice violations and data integrity concerns.

Manufacturing compliance issues complicated FDA’s review of Gilead Sciences Inc.’s Sovaldi (sofosbuvir), requiring the company to withdraw two facilities from the NDA late in the review process and raising questions about its ability to meet expected patient demand for the chronic hepatitis C drug.

CDER’s Office of Compliance had “some serious concerns” with two of the 11 manufacturing, testing and packaging sites for active pharmaceutical ingredient and finished drug product that were named in the original NDA, FDA review documents state

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