AstraZeneca PLC (AZN) and Bristol-Myers Squibb Company (BMY) Resubmit Dapagliflozin New Drug Application for the Treatment of Type 2 Diabetes in the U.S.
7/25/2013 11:29:17 AM
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AstraZeneca and Bristol-Myers Squibb today announced they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes. The NDA resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to four years' duration) from previously submitted studies. Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin.
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