FDA pulls unproven premature birth drug Makena from market.

The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, from the US market after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The FDA expedited Makena's approval in 2011 based on a small study, but a larger study completed in 2018 showed the drug neither reduced premature births nor resulted in healthier outcomes for babies.