Makena’s days on the US market appear numbered after a Food and Drug Administration advisory committee voted overwhelmingly on 19 October that Covis Pharma’s preterm birth prevention drug should be withdrawn.
US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close
Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.
