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See Latest ArticlesU.S. Food and Drug Administration Extends Review Timeline for ONGLYZA (saxagliptin) New Drug Application
Bristol Myers-Squibb Company, 04/24/09
Bristol-Myers Squibb Company and AstraZeneca reported today that the U.S. Food and Drug Administration has determined it needs additional time to complete the review of the New Drug Application for ONGLYZA for the treatment of type 2 diabetes. Accordingly, the FDA has extended the Prescription Drug User Fee Act date from April 2009 to July 2009. The NDA for ONGLYZA was submitted to the FDA on June 2008. The companies continue to work closely with the FDA to support the review of ONGLYZA.
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