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After a years-long controversy, the U.S. Food and Drug Administration ordered the immediate withdrawal of a drug that had been widely used to prevent premature births, even though clinical trial data indicated the medication failed to do so.

The manufacturer, Covis Pharma, earlier this year agreed to withdraw the treatment, which is known as Makena. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries, although generic versions have since become available, and these will also now be withdrawn.


The withdrawal caps an unusual episode in which the company battled the FDA over its authority to have medicines removed from the market. Makena was approved more than a decade ago, but its effectiveness was thrown into doubt after results of a required follow-up clinical trial failed to verify a benefit. Yet Covis fought a request by the FDA to withdraw the drug.

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