Provider Alert! FDA Withdrawal of Makena®
Date: April 10, 2023 Attention: All Providers Effective Date: April 06, 2023 Call to action: Effective April 6, 2023, the U.S. Food and Drug Administration (FDA) announced the final decision to withdraw the approval of Makena and its generics, which was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics are no longer FDA approved and cannot be lawfully distributed. This is in result due to...
