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

The U.S. Food and Drug Administration’s (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee’s recommendation on October 29, 2019 has led to some confusion in the healthcare community about the current status of Makena. At this time, it is important to know that Makena’s approval and product label remain unchanged.

You may learn more about the current clinical medical association guidelines by visiting 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 1-617-498-3300 or contactus@amagpharma.com.