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Kombiglyze XR Approval History

  • FDA approved: Yes (First approved November 5th, 2010)
  • Brand name: Kombiglyze XR
  • Generic name: saxagliptin and metformin
  • Dosage form: Extended-Release Tablets
  • Company: Bristol-Myers Squibb Company and AstraZeneca
  • Treatment for: Diabetes, Type 2

Kombiglyze XR (saxagliptin and metformin) is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin) and extended release metformin for the treatment of type 2 diabetes.

Development History and FDA Approval Process for Kombiglyze XR

DateArticle
Nov  5, 2010Approval Kombiglyze XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults
Mar 22, 2010U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults

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