Withdrawing Approval of Makena—A Proposal From the FDA Center for Drug Evaluation and Research

Abstract

(Abstracted from N Engl J Med 2020;383:e131(1)–e131(4)) Makena (hydroxyprogesterone caproate injection) is currently the only drug on the market for the prevention of recurrent preterm birth (PTB). The Food and Drug Administration (FDA) granted accelerated approval for this drug in 2011.