Public Citizen To FDA: Withdraw Approval Of Makena And Its Generics

Public Citizen is calling on FDA to withdraw approval of all hydroxyprogesterone caproate-containing drugs, including the brand drug Makena, which are used to reduce risk of preterm birth in women. Postmarket studies that were required as a condition of Makena’s approval have failed to verify the drug provides significant clinical benefit over placebo, and an FDA panel will convene in three weeks to consider the trial’s findings. In a citizen petition filed Tuesday (Oct. 8), Public Citizen calls for FDA...