Brand Name Review By FDA: Predictability Returns To Process
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.
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The Center for Drug Evaluation & Research granted 74% of the proprietary names it evaluated between October 1, 2013 and August 31, 2014. That is a big improvement from rejection rates of over 50% just a few years ago.
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.
The medullary thyroid cancer drug's Risk Evaluation and Mitigation Strategy requires mandatory enrollment and certification of prescribers and pharmacists, which should help ensure the drug is used primarily in patients with symptomatic, progressive disease.