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Multiple Aspirin Dose Analyses Reassured FDA On Brilinta’s U.S. Efficacy

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The consistency of numerous analyses supporting a negative interaction between ticagrelor and high-dose aspirin, as used in the U.S., helped overcome FDA’s initial reluctance to approve AstraZeneca’s platelet inhibitor without a new trial.

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