FDA again delays approval of Bristol-Myers and Pfizer's Eliquis

26 June 2012

A few days ahead of the expected decision date, the US Food and Drug Administration on Monday issued a complete response letter (CRL) regarding Bristol-Myers Squibb (NYSE: BMY) and Pfizer’s (NYSE: PFE) New Drug Application for their anticoagulant Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The agency put Eliquis on “fast track” last year, indicating early approval.

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