FDA forces unproven premature birth drug Makena off market

WASHINGTON (AP) — 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.

The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. 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.

In recent months, Covis finally bowed to FDA pressure, proposing a “winding down” period of several months so that women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.

“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said in a statement.