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news.Adeza has said that the FDA will approve its product Gestiva for premature birth subject to an additional animal study and certain other conditions.
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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 Anderson, president and CEO.
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.
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. There are currently no treatments approved by the FDA for premature birth.
Adeza designs, manufactures and markets innovative products for women's health.