Withdrawing Approval of Makena -- A Proposal from the FDA Center for Drug Evaluation and Research.

The article discusses a proposal from the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) to withdraw approval of Makena (hydroxyprogesterone caproate injection) on October 5, 2020. Topics discussed include basis of the approval by the FDA, basis for the conclusion of CDER that withdrawal of Makena is warranted, and how CDER views the contradictory results from randomized trials.