Makena
Generic name: hydroxyprogesterone caproate
Treatment for: Premature Labor
Adeza Receives FDA Approvable Letter for Gestiva
SUNNYVALE, Calif., October 23, 2006 - Adeza today announced that the U.S. Food and Drug Administration (FDA) has determined that Gestiva for the prevention of preterm birth in women with a history of preterm delivery is approvable subject to the completion of an additional animal study and certain other conditions. The approvable letter also outlined post-approval clinical requirements, which are consistent with recommendations made by the FDA advisory committee in August 2006.
"We will request a meeting with the FDA to address comments outlined in the approvable letter as soon as possible," said Emory V. Anderson, president and chief executive officer. "Currently there is no FDA-approved treatment for preterm birth, which represents a major and costly public health issue in the U.S."
Gestiva is a long-acting form of a naturally occurring progesterone. 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.
A decision by the FDA regarding three-year exclusivity under Hatch-Waxman for Gestiva is expected to be made at the time of any final approval. Discussions with the FDA regarding the company's Orphan Drug application for seven-year exclusivity are ongoing. While Adeza's initial request for Orphan Drug designation was not granted, the company plans to meet with the FDA to provide additional new information for further review by the Agency.
Posted: October 2006
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- K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva - January 12, 2011
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- FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth - August 29, 2006
- Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births - July 18, 2006
- FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births - July 6, 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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