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FDA Pulls Pre Term Birth Prevention Drug

U.S. Food and Drug Administration FDA announced decision to withdraw approval of Makena® hydroxyprogesterone caproate injection, drug approved in 2011 to reduce risk of preterm birth in certain pregnant women. ....

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Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway | Sheppard Mullin Richter & Hampton LLP

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug. ....

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