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Makena FDA Approval History

Last updated by Judith Stewart, BPharm on April 7, 2023.

FDA Approved: Yes (Discontinued) (First approved February 3, 2011)
Brand name: Makena
Generic name: hydroxyprogesterone caproate
Dosage form: Injection
Previous Name: Gestiva
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Premature Labor

Makena (hydroxyprogesterone caproate) was a long acting form of natural progesterone approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth.

  • On 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. The decision was issued jointly by the FDA Commissioner and Chief Scientist. Makena and its generics are no longer approved and cannot lawfully be distributed.

Development timeline for Makena

Apr  6, 2023FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
Feb 14, 2018Approval AMAG Pharmaceuticals Announces FDA Approval of Makena (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women
Feb  4, 2011Approval FDA Approves Makena to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Jan 12, 2011K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva
Jan 26, 2009KV Pharmaceutical's Launch of Gestiva Delayed
Oct 21, 2008KV Provides Update on Gestiva PDUFA Date
Jan 22, 2008Hologic Announces Sale of Gestiva
Oct 23, 2006Adeza Receives FDA Approvable Letter for Gestiva
Aug 29, 2006FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth
Jul 18, 2006Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births
Jul  6, 2006FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
Jun  5, 2006FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births
May  4, 2006Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births

Further information

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