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US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close

Executive Summary

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.

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