After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs
Fierce Pharma
MAY 17, 2024
Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.
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