The company submitted the new drug application (NDA) in May and the FDA gave priority review status to the application in June. The FDA has set a priority review goal to respond to the Gestiva NDA by October 20, 2006. The application for Gestiva includes data from a clinical study conducted by the US National Institutes of Health (NIH).
“We are pleased that the Gestiva NDA is moving forward in the regulatory process,” said Emory Anderson, president and CEO. “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, it will be the only NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.