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Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research
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Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research
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Journal Article
Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research
2020
Overview
The FDA’s Center for Drug Evaluation and Research has recommended withdrawing the approval of Makena for the prevention of recurrent preterm birth after a trial failed both to verify clinical benefit to neonates and to substantiate a reduction in preterm birth.
Publisher
Massachusetts Medical Society
Subject
17 alpha-Hydroxyprogesterone Caproate - therapeutic use
/ Birth
/ Europe
/ Female
/ Humans
/ Neonates
/ Premature Birth - epidemiology
/ Premature Birth - prevention & control
/ Product Recalls and Withdrawals
/ Progestins - therapeutic use
/ United States - epidemiology
