FDA Forces Unproven Premature Birth Drug Makena Off Market

April 6, 2023

(Associated Press) – 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. (Read More)