“Marginal” Mortality Benefit Belongs In Eliquis’ Label, But Not The Indication Statement, FDA Says
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Although apixaban demonstrated a significant benefit on all-cause mortality in the ARISTOTLE trial, the statistical fragility of the finding meant the data were relegated to the label’s Clinical Studies section.
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Review Of Reviews: Drug Review Profiles 2013
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.
Review Of Reviews: Drug Review Profiles 2013
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.