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FDA delays decision on Pfizer, Bristol-Myers drug

FDA delays decision on Pfizer, Bristol-Myers drug

June 25th, 2012 in News

TRENTON, N.J. (AP) - Shares of Pfizer Inc. and Bristol-Myers Squibb Co. fell Monday after federal regulators unexpectedly delayed for a second time a decision on whether to approve the companies' highly touted experimental anticlotting drug Eliquis.

Some analysts see Eliquis as better than two new clot-preventing pills that beat it to market, but the latest delay means a U.S. launch of Eliquis likely won't happen until next year.

The Food and Drug Administration said it wants more information on "data management and verification" from a huge international study called ARISTOTLE that examined how well Eliquis prevented strokes in patients with an irregular heartbeat called atrial fibrillation, the drugmakers said Monday.