FDA Delays Approval Of Pfizer-BMS Anti-Clotting Drug

Law360, New York (March 1, 2012, 5:36 PM EST) -- The U.S. Food and Drug Administration has given itself three more months to review new data before deciding whether to approve an drug designed to reduce the risk of blood clots and prevent stroke and systemic embolism, Pfizer Inc. and Bristol-Myers Squibb Co. announced Wednesday.

The FDA is extending its decision deadline to June 28 for the companies' New Drug Application for Eliquis, an anti-clotting drug Pfizer and Bristol-Myers have been developing together since 2007 for patients with an irregular heartbeat, the companies said in a...
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