Aquavan NDA Accepted by FDA

The FDA has accepted MGI Pharma’s new drug application (NDA) for Aquavan, which is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures.

MGI submitted the NDA for Aquavan (fospropofol disodium) Sept. 27. 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 application, according to MGI.

Under the Prescription Drug User Fee Act, the agency intends to take action on the NDA by July 26, 2008.