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FDA Requests More Time to Review Saxagliptin Application

PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) and AstraZeneca (NYSE: AZN - News) reported today that the U.S. Food and Drug Administration (FDA) has determined it needs additional time to complete the review of the New Drug Application (NDA) for saxagliptin (Onglyza) for the treatment of type 2 diabetes. Accordingly, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from April 30, 2009 to July 30, 2009. The NDA for ONGLYZA was submitted to the FDA on June 30, 2008. The companies continue to work closely with the FDA to support the review of Onglyza.

Onglyza is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The Onglyza application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise, use in combination with three types of commonly used oral anti-diabetic (OAD) medications - metformin, thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not provide adequate glycemic control, as an adjunct to diet and exercise – and use in initial combination therapy with metformin, as an adjunct to diet and exercise.

Source: Bristol-Myers Squibb Company

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