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PRINCETON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.
The FDA accepted the application for dapagliflozin, an investigational drug for adults with the disease. The Centers for Disease Control and Prevention estimated that 1-in-11 U.S. adults has diabetes, with 90% to 95% of them having Type 2 diabetes.
The agency expects to take action on the application in late October.