FDA may withdraw approval of drug that manufacturer says prevents preterm birth
A Food and Drug Administration advisory committee recently voted in favor of withdrawing the agency’s approval of Makena, a synthetic progestin, for the prevention of preterm birth in pregnant women who have a history of preterm birth. According to Amag Pharmaceuticals, which manufactures Makena, the FDA committee came to its decision after a confirmatory trial concluded that the treatment did not decrease the risk for recurrent preterm birth. The findings contradict those that led the FDA to approve an injectable form of the drug in 2011.
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