For US Patients Only
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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 or concerns about receiving your therapy as prescribed, consult your healthcare provider. 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–8:00 PM ET.