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Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial

 
• By Sue Sutter

Despite expectations that Bristol-Myers Squibb/Pfizer’s novel oral anticoagulant apixaban would sail through FDA on the strength of the superior efficacy and safety compared to warfarin in the ARISTOTLE trial, study conduct issues led to a nine-month delay in approval.

Concerns surrounding the conduct of the ARISTOTLE pivotal trial twice led FDA to delay approval of Bristol-Myers Squibb Co./Pfizer Inc.’s antithrombin Eliquis (apixaban).

The oral anticoagulant’s approval was delayed by nine months, from its original PDUFA date of March 28, 2012 to its Dec

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