FDA sets March 2013 PDUFA date for re-submitted Eliquis
The US Food and Drug Administration has acknowledged receipt of the New Drug Application resubmission for pharma major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of March 17, 2013.
The FDA has deemed the resubmission a complete response to its June Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial (The Pharma Letter June 26).
Will compete with Pradaxa and Xarelto
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