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FDA forces unproven premature birth drug Makena off market


AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market. The decision announced Thursday follows years of delays by drugmaker Covis Pharma, which repeatedly asked the FDA for more time to study the drug. Makena is the only medication to receive FDA approval to help reduce the risk of early births. The drug was approved in 2011 based on early research suggesting it helped women with a history of miscarriages and premature deliveries. But follow-up studies failed to show the drug resulted in better results for women or their babies.

Article Topic Follows: AP National Business

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