FDA Withdraws Approval of Makena.

The FDA has withdrawn approval of Makena, a drug used to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, due to a lack of clinical benefit. The drug was approved under the accelerated approval pathway in 2011, but a post-marketing confirmatory study did not verify clinical benefit. The FDA recognizes the need for effective treatments for preterm birth, which has a disparate impact on communities of color, especially Black women. Patients with questions should talk to their healthcare provider.