MGI PHARMA Announces Aquavan NDA Accepted for Review by U.S. FDA
Monday December 17, 7:01 am ET
PDUFA Date of July 26, 2008 Established
MINNEAPOLIS--(BUSINESS WIRE)--MGI PHARMA, INC. (Nasdaq:MOGN - News), a biopharmaceutical company focused in oncology and acute care today announced that the New Drug Application (NDA) for Aquavan® (fospropofol disodium) Injection was accepted for filing by the United States Food and Drug Administration (FDA). Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures.
The 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. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aquavan Injection. Under PDUFA (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 2 and phase 3 trials in patients undergoing colonoscopy, a phase 3 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.
About Aquavan® (fospropofol disodium) Injection
Aquavan® (fospropofol disodium) Injection, a proprietary water-soluble prodrug of propofol that, after intravenous injection, is rapidly converted by an enzyme (alkaline phosphatase) in the body into propofol, is a product candidate in development for sedation of patients undergoing diagnostic or therapeutic procedures. Aquavan has not been approved for marketing by the U.S. Food and Drug Administration (U.S. FDA) or any other regulatory agencies. <snip> |
