For US Healthcare Providers Only
Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history
On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena®. FDA has stated that it recognizes that a limited supply of these drugs has already been distributed, including to physicians’ offices and pharmacies. FDA acknowledges that some health care providers might continue to prescribe or administer that limited remaining supply to their patients. However, we recommend health care practitioners consider FDA’s conclusions.
If you have questions about the status of your prescription, or would like to talk with a Care Manager, please call 1-800-847-3418, Monday–Friday from 8:00 AM–5:00PM EST.