STAT+: FDA withdraws approval of controversial drug to prevent preterm births
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. These will also now be withdrawn.
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