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

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.

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Bibliographic Details
Published in:	The New England journal of medicine Vol. 383; no. 24; p. e131
Main Authors:	Chang, Christina Y, Nguyen, Christine P, Wesley, Barbara, Guo, Jia, Johnson, Laura Lee, Joffe, Hylton V
Format:	Journal Article
Language:	English
Published:	United States Massachusetts Medical Society 10-12-2020
Subjects:	17 alpha-Hydroxyprogesterone Caproate - therapeutic use Advisory Committees Birth Black or African American Black People Clinical Trials as Topic Drug Approval Enrollments Europe FDA approval Female Humans Infant, Newborn Neonates Pregnancy Premature birth Premature Birth - epidemiology Premature Birth - ethnology Premature Birth - prevention & control Product Recalls and Withdrawals Progestins - therapeutic use Public hearings Risk Factors Treatment Outcome United States - epidemiology United States Food and Drug Administration Womens health United States Europe United States > US
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Description
Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0028-4793 1533-4406 1533-4406
DOI:	10.1056/NEJMp2031055