Nuvigil action date extension
This article was originally published in Pharmaceutical Approvals Monthly
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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