FDA accepts Adeza's New Drug Application for Gestiva to prevent preterm births

By E. Janene Geiss

Philadelphia, July 6 - Adeza said Thursday that the Food and Drug Administration has accepted for filing the company's New Drug Application 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, Adeza announced its submission of the Gestiva application, which includes data from a clinical study conducted by the National Institutes of Health, officials said in a company news release.

The application for Gestiva was granted priority review status by the FDA in June.

Under Prescription Drug User Fee Act guidelines, the FDA has set a priority review goal to respond to the Gestiva application by Oct. 20.

The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists in the treatment of women for recurrent preterm birth.

Adeza is a Sunnyvale, Calif., pharmaceutical company focused on women's health.

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