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Brilinta Panel Leaves FDA With The Task Of Crafting Labeling That Describes Poor U.S Efficacy Results

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Cardiovascular and Renal Drugs Advisory Committee votes 7-1 in favor of ticagrelor's approval for acute coronary syndromes despite rejecting AstraZeneca's aspirin-dosing theory as the sole cause of lack of benefit in the U.S. population.

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