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