FDA Again Delays Approval Of Pfizer-BMS Anti-Clotting Drug

Law360, New York (June 25, 2012, 2:54 PM EDT) -- The U.S. Food and Drug Administration has again delayed its decision on whether to approve a drug designed to reduce the risk of blood clots and prevent stroke and systemic embolism, Pfizer Inc. and Bristol-Myers Squibb Co. said Monday.

The drugmakers said the FDA has asked them to provide additional information on data management and verification on one of two clinical studies conducted on Eliquis, an anti-clotting drug Pfizer and Bristol-Myers have been developing together since 2007 for patients with an irregular heartbeat.

The companies said...
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