Makena receives FDA approval

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

Makena will be manufactured by Baxter for KV Pharmaceutical/Ther-Rx. Ther-Rx, which will market the drug, said it will be available in March. Makena is a specialty injectable and will be available through a network of specialty pharmacies and distributors that specialize in distributing specialty injectables and will be express mailed directly from the pharmacy/distributor to the healthcare provider or to the patient, depending on the preferred location for administration of weekly injections.

“Preterm birth is a significant public health issue in the United States,” FDA Office of New Drugs deputy director Sandra Kweder said. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”