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Bristol-Myers Squibb and Pfizer announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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Primary venous thromboembolism prophylaxis with apixaban, an oral direct Factor Xa inhibitor, in ambulatory cancer patients undergoing first- or second-line chemotherapy for advanced or metastatic cancer, is safe and well tolerated.

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Bristol-Myers Squib and Pfizer announced results from their Phase 3 ARISTOTLE study of Eliquis (apixaban tablet) in patients with atrial fibrillation (AF) and at least one additional risk factor for stroke.