Makena® (hydroxyprogesterone caproate injection) Approval and Product Label Remain Unchanged

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) informed AMAG Pharmaceuticals on October 5, 2020 that it is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). At this time, it is important to know that Makena’s approval and product label remain unchanged. Patients should not stop taking Makena without consulting their healthcare provider.

The product continues to remain available to patients and prescribers. You may learn more about current medical society guidelines by visiting the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine.

If you have any questions, we welcome you to contact AMAG Pharmaceuticals at 1-877-411-2510 or amag@druginfo.com.