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US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close

 
• By Sue Sutter

Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.

Makena thumbs down
• Source: Shutterstock

Makena’s days on the US market appear numbered after a Food and Drug Administration advisory committee voted overwhelmingly on 19 October that Covis Pharma’s preterm birth prevention drug should be withdrawn.

Capping a three-day public hearing on the Center for Drug Evaluation and Research’s proposal to withdraw accelerated approval of Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17-P), 14 of 15 members of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted against keeping

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