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ONGLYZA-metformin combination: FDA accepts NDA for review

Published on March 17, 2010 at 9:45 AM · No Comments

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.

The NDA is based on bioequivalence data and data from the ONGLYZA phase 3 clinical trial program which included studies for the co-administration of ONGLYZA and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve adult patients.

Source Bristol-Myers Squibb

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Posted in: Drug Trial News | Medical Condition News

Tags: Atazanavir, Blood Sugar, Creatinine, Diabetes, Diabetes Mellitus, Diabetic Ketoacidosis, Dialysis, Diet, Edema, Exercise, Headache, Hypoglycemia, Insulin, Metformin, Neuroscience, New Drug Application, Nursing, Oncology, Onglyza, Pregnancy, Ritonavir, Saxagliptin, Thiazolidinediones, Type 1 Diabetes, Type 2 Diabetes, Urinary Tract Infection

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