FDA Forces Unproven Premature Birth Drug Makena Off the Market

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The FDA on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births

Covis Pharma—APWASHINGTON — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women.

“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said in a statement. The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.

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