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Bristol-Myers Squibb Company
U.S. Food and Drug Administration Extends Review Timeline for ONGLYZA™ saxagliptin New Drug Application
May 16th, 2009
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) reported 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 ONGLYZA™ (saxagliptin) 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...
Source: Law & Health Weekly (2009-05-16)
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