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Makena Sponsor Covis Seeks To Use FDA Officials’ Words, Actions On Accelerated Approval Against CDER

 
• By Sue Sutter

Company cites comments by Oncology Center of Excellence Director Richard Pazdur and Office of Neuroscience Director Billy Dunn on reasons why confirmatory trials fail and the need for regulatory flexibility. Ironically, both senior officials have publicly extracted commitments from companies to withdraw products if postmarketing trials do not verify clinical benefit.

U-turn
Covis is using senior agency officials' words in its case against CDER's arguments for Makena's removal. • Source: Shutterstock

Covis Pharma is trying to use the US Food and Drug Administration’s words, actions and inactions on accelerated approval against the Center for Drug Evaluation and Research in the company’s bid to keep the preterm birth prevention drug Makena (hydroxyprogesterone caproate) on the market.

In its briefing document for the 17-19 October public hearing on CDER’s proposal to withdraw Makena, Covis cites FDA...

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