FDA Commissioner and Chief Scientist Announce Decision toWithdraw Approval of Makena

April 6, 2023 - The U.S. Food and Drug Administration 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 immediately, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.

The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study. The ensuing confirmatory study did not verify clinical benefit and the FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug’s approval in 2020. The sponsor requested a hearing, which was held in October 2022.

Following the hearing, the FDA Commissioner and Chief Scientist reviewed the record for this matter, including the submissions by CDER and sponsor Covis Pharma, public comments to the docket, the transcript of the hearing and the Presiding Officer’s report. Based on that review, they have decided to withdraw approval of Makena and generic versions of Makena.

The decision issued today by the FDA Commissioner and Chief Scientist outlines their rationale and also recognizes the crucial need to develop treatments to reduce the serious risks associated with preterm birth.

While the approvals of Makena and its generics have been withdrawn, the agency recognizes that there is a supply of product that has already been distributed. Patients who have questions should talk to their healthcare provider. Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved. For additional information, see Makena Information on FDA.gov.