The U.S. Food and Drug Administration (FDA) on Thursday withdrew its approval for Covis Pharma’s preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.
Tag Archive for: Makena
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.
