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News source: Business Wire Bristol-Myers Squibb Company and AstraZeneca today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA(TM) (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin. The NDA and MAA submissions for saxagliptin are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naive... [read full story]
