6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. 

This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. The decision was issued jointly by the FDA Commissioner and Chief Scientist. Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.

Read FDA press release