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The FDA, after analyzing patient testing data for Xarelto, turned down a request by J&J and Bayer to let them claim it's superior to warfarin at preventing strokes and blood clots. Instead the companies can only say it works about the same. The first new anti-clotting drug, Pradaxa from German drugmaker Boehringer Ingelheim GmbH, was approved in October 2010 for patients with atrial fibrillation. Also called dabigatran, it inhibits an enzyme called thrombin that's essential for clot formation. Meanwhile, partners Bristol-Myers Squibb Co. and Pfizer Inc. four weeks ago applied for FDA approval of their Eliquis for preventing strokes and blood clots in atrial fibrillation patients. The drug is getting a priority review, with a target date of March 28 for a decision, according to the companies. Eliquis, also called apixaban, was approved in the 27 European Union countries in May for preventing blood clots in patients getting hip or knee replacement surgery.
[Associated
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