U.S. FDA Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Bristol-Myers Squibb Company And AstraZeneca PLC’s Onglyza(TM) (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults

PRINCETON, N.J. & WILMINGTON, Del.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.

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