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Shades Of Prasugrel: Brilinta Review Felt The Effects Of Effient’s Experience

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s review of AstraZeneca’s platelet inhibitor ticagrelor was tinged by the agency’s earlier evaluation and delayed approval of Lilly/Daiichi’s prasugrel for acute coronary syndromes.

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Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.

Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.

Brilinta Review Sparks War Of Words Between FDA Cardio-Renal Division’s Marciniak, Stockbridge

The ticagrelor NDA ignited strong opinions from the cross-discipline team leader about sponsor AstraZeneca’s conduct, drawing a forceful response from the review division director.

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