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 Makena, please call our Medical Information Call Center at +1-877-411-2510, Monday-Friday from 9:00 AM-7:00 PM EST.
Please see Full Prescribing Information for Makena.
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PP-MKN-US-00713 08/23