Makena
Generic name: hydroxyprogesterone caproate
Treatment for: Premature Labor
FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
SUNNYVALE, Calif., July 6, 2006 - Adeza today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for Gestiva, a long-acting form of a naturally occurring progesterone to prevent preterm birth in women with a history of preterm delivery. In May 2006, Adeza announced its submission of the Gestiva NDA, which includes data from a clinical study conducted by the National Institutes of Health (NIH). The NDA for Gestiva was granted Priority Review status by the FDA in June 2006. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a priority review goal to respond to the Gestiva NDA by October 20, 2006.
"We are pleased that the Gestiva NDA is moving forward in the regulatory process," said Emory V. Anderson, president and chief executive officer. "Gestiva has the potential to significantly reduce the risk of preterm birth in one of the highest risk groups, women with a history of preterm delivery."
The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists (ACOG) in the treatment of women for recurrent preterm birth. If Gestiva receives FDA approval, Adeza will have the only NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.
Posted: July 2006
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- K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva - January 12, 2011
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- Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births - July 18, 2006
- FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births - June 5, 2006
- Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births - May 4, 2006
Makena (hydroxyprogesterone caproate) FDA Approval History
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