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Onglyza Approval History

FDA Approved: Yes (First approved July 31, 2009)
Brand name: Onglyza
Generic name: saxagliptin
Dosage form: Tablets
Company: 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

DateArticle
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

Further information

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