The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena. The agency will discuss the drug on Oct. 17-19.

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.