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AstraZeneca PLC and Bristol-Myers Squibb Co Resubmit New Drug Application for Dapagliflozin


Thursday, 25 Jul 2013 07:43am EDT 

AstraZeneca PLC announced that the company and Bristol-Myers Squibb Co 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.