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Qtern Approval History

  • FDA approved: Yes (First approved February 27th, 2017)
  • Brand name: Qtern
  • Generic name: dapagliflozin and saxagliptin
  • Dosage form: Tablets
  • Company: AstraZeneca
  • Treatment for: Diabetes, Type 2

Qtern (dapagliflozin and saxagliptin) is a 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.

Development History and FDA Approval Process for Qtern

Feb 28, 2017Approval FDA Approves Once-Daily Qtern (dapagliflozin and saxagliptin) Tablets for Adults with Type-2 Diabetes
Oct 16, 2015AstraZeneca Receives Complete Response Letter for Saxagliptin/Dapagliflozin Fixed-Dose-Combination
May 13, 2014AstraZeneca Announces Positive Results from Phase III study of Saxagliptin/Dapagliflozin Combination

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