FDA pulls preterm birth drug Makena immediately.
The FDA has ordered Covis Pharma to immediately withdraw its preterm birth drug Makena from the market, following a failed confirmatory trial and a 14-1 vote by an FDA advisory committee to pull the drug. Covis Pharma had previously expressed willingness to withdraw the drug and had sought a wind-down period. The FDA has now stated that Makena and its generics are no longer approved and cannot be distributed in interstate commerce.