U.S. drug regulators on April 6 said they’re withdrawing the approval of a drug aimed at reducing preterm birth in pregnant women.
The U.S. Food and Drug Administration (FDA) is withdrawing approval for Makena, which the same agency approved in 2011.
The decision stems from the conclusion that there’s no evidence Makena actually reduces the risk of preterm birth.
“The touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” Dr. Robert Califf, the FDA’s commissioner, and FDA Chief Scientist Namandjé Bumpus said in their decision….