Bristol-Myers Squibb Co (BMY) and Pfizer (PFE) announced that FDA has extended action date for Eliquis by three months.
FDA extended action date for the New Drug Application or NDA for Eliquis for prevention of stroke and systemic embolism in patients with atrial fibrillation. The new Prescription Drug User Fee Act goal date is June 28.
Subsequent to NDA filing, the companies submitted additional information about the Eliquis clinical program to FDA, which constitutes a major amendment to application and will require additional time for review.
The companies stated that they will continue to work closely with the agency to support the continued review of the NDA for Eliquis.
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