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Dapagliflozin and saxagliptin Approval Status

Dapagliflozin and saxagliptin is an investigational sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

In October 2015, AstraZeneca announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for the dapagliflozin and saxagliptin combination had not been approved.

Development Status and FDA Approval Process for dapagliflozin and saxagliptin

Oct 16, 2015AstraZeneca Receives Complete Response Letter for Saxagliptin/Dapagliflozin Fixed-Dose-Combination

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