What’s In A Name? Janssen’s Loss Of Sovriad Was Gilead’s Gain With Sovaldi
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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CDER now granting 86% of sponsors’ preferred proprietary names prior to launch – a significant improvement over just five years ago that seems driven in part by several new guidance documents.
FDA’s Center for Drug Evaluation & Research is now granting 86% of drug sponsors’ preferred proprietary trade names prior to launch – a significant improvement over just five years ago. Better communication between FDA and drugs sponsors – including the development of several new guidance documents – has resulted in a much more predictable review of proprietary trade names.
Request for information indicates agency’s approach to allow sponsors to hold proprietary names pre-approval may still be too tepid for industry.