FDA Revokes Approval for Drug for Pregnant Women

A sign for the Food And Drug Administration is seen outside of the headquarters in White Oak, Maryland, on July 20, 2020. Sarah Silbiger/Getty Images

U.S. drug regulators are withdrawing the approval of a drug aimed at reducing preterm births in pregnant women.

The U.S. Food and Drug Administration (FDA) is withdrawing approval for Makena, which it had approved in 2011. The decision stems from the conclusion that there’s no evidence Makena actually reduces the risk of preterm birth.