FDA lays the finishing touches on its plan to pull Makena
FDA is going to be issuing its final decision soon on whether or not to pull the longstanding accelerated approval for Covis’ controversial prenatal drug Makena, while another nail is driven into the drug’s coffin.
CDER deputy director Celia Witten wrote in a report summary on the FDA’s adcomm meeting on Makena to FDA Commissioner Robert Califf and chief scientist Namandjé Bumpus Friday that she does not believe that Makena “has been shown to be effective,” either in the current population or a more limited population for the drug that Covis proposed.
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