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BioWorld - Monday, July 13, 2026
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End of the road for Makena?

Oct. 5, 2020
By Mari Serebrov
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA is proposing its withdrawal from the U.S. market because the required postmarketing study didn’t show clinical benefit.
BioWorld Drugs Regulatory Genitourinary/sexual function

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