The new drug application (NDA) for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA’s determination that the application is sufficiently complete to permit a substantive review of the data. Under the Prescription Drug User Fee Act III, the FDA’s goal is to review and act on the NDA by July 26, 2008.
Data from Phase II and Phase III trials in patients undergoing colonoscopy, a Phase III trial in patients undergoing bronchoscopy, and an open-label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan NDA. In total, data from 21 clinical studies, including 1,611 subjects are included in the application.