FDA pulls preterm-birth drug Makena and its generics from market after 12 years

The U.S. Food and Drug Administration said Thursday it had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment hit the market.

The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition.

The…