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Onglyza Approval History

  • FDA approved: Yes (First approved July 31st, 2009)
  • Brand name: Onglyza
  • Generic name: saxagliptin
  • Dosage form: Tablets
  • Company: Bristol-Myers Squibb Company and AstraZeneca
  • Treatment for: Diabetes, Type 2

Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.

Development History and FDA Approval Process for Onglyza

Jul 31, 2009Approval FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes
Apr 23, 2009U.S. Food and Drug Administration Extends Review Timeline for Onglyza (saxagliptin) New Drug Application
Apr  2, 2009Onglyza (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee
Jul 23, 2008Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes

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