The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makenna.

On Tuesday, Covis Pharma GmbH announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial pre-term birth prevention drug Makena (hydroxyprogesterone caproate injection). Makena was previously marketed by AMAG Pharmaceuticals, which was acquired by Covis in October 2020.