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What’s In A Name? Janssen’s Loss Of Sovriad Was Gilead’s Gain With Sovaldi

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA initially rejected both sponsors’ preferred proprietary names for their hepatitis C treatments due to the risk of confusion with each other. Janssen had to settle for Olysio, its backup name for simeprevir, leaving Gilead to claim title to its preferred name for sofosbuvir.

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Olysio Reviewers

FDA staff that participated in the review of Janssen’s simeprevir for chronic hepatitis C.

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