FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes

Bristol-Myers Squibb Company BMY and AstraZeneca AZN today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus.

A Marketing Authorisation Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency (EMA). The NDA and MAA submissions for dapagliflozin were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is October 28, 2011.