AstraZeneca and Bristol-Myers Squibb resubmit dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S

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.