Makena's accelerated approval withdrawal hearing set for October as Covis wants to do more research
The long-awaited FDA hearing to review Covis Pharma’s accelerated approval for its controversial preterm birth injection, which failed its confirmatory trial, will take place from Oct. 17-19.
The FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee will conduct the hearing about the future of Makena (hydroxyprogesterone caproate injection), the company said in a statement yesterday.
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