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In an unexpected turn of events, the Food and Drug Administration will hold a hearing on whether Covis Pharma should voluntarily withdraw its controversial treatment for preventing premature births after a key study found the medicine is ineffective.

The move comes nearly two years after an FDA advisory panel recommended that the medication, known as Makena, should be withdrawn after the trial failed to verify a clinical benefit. The 9-to-7 vote called into question the future of a medication that has been the standard of care across the U.S. since it was approved a decade ago.

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The FDA had required a follow-up study as a condition of endorsing the medicine under its accelerated approval process. But the study found Makena, also known as hydroxyprogesterone caproate, failed to decrease recurrent premature births in women versus a placebo. By contrast, the 2003 study on which the FDA relied to approve the drug found more than a 30% reduction in preterm births.

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