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Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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Review Of Reviews: Drug Review Profiles 2013

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.

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