FDA To Withdraw Approval Of Controversial Preterm Pregnancy Drug Makena

Mealey's (October 9, 2020, 3:51 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Oct. 5 notified AMAG Pharma USA Inc. and five other drug companies that the agency is proposing to withdraw approval of Makena-brand hydroxyprogesterone caproate because a post-marketing clinical trial failed to verify that the drug has a clinical benefit and because the drug is not shown to be effective under its conditions for use....

Related Sections