Dapagliflozin and saxagliptin Approval Status
- FDA approved: No
- Generic name: dapagliflozin and saxagliptin
- Company: AstraZeneca Pharmaceuticals LP
- Treatment for: Diabetes, Type 2
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, 2015||AstraZeneca Receives Complete Response Letter for Saxagliptin/Dapagliflozin Fixed-Dose-Combination|
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