Makena Approval History
FDA Approved: Yes (First approved February 3, 2011)
Brand name: Makena
Generic name: hydroxyprogesterone caproate
Dosage form: Injection
Previous Name: Gestiva
Company: Hologic, Inc.
Treatment for: Premature Labor
Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women.
Development History and FDA Approval Process for Makena
|Feb 14, 2018|| 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|| 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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