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Nuvigil action date extension

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's revised user fee date for Cephalon's excessive daytime sleepiness agent Nuvigil (armodafinil) is April 30 following a 90-day extension. The agency deemed additional information, submitted in October, to be a major amendment to Cephalon's NDA. The firm maintains that it does not expect further delays and continues to expect a mid-2006 launch. Nuvigil is a follow-on compound to Cephalon's sleepiness agent Provigil (modafinil), which could see generic competition by mid-2006...

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