SUNNYVALE, Calif.--(BUSINESS WIRE)--July 6, 2006--Adeza (NASDAQ:ADZA - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for Gestiva(TM), 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.
