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Nuvigil Label Likely To Include Safety Information From Sparlon Trials

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Final approved labeling for Cephalon’s Nuvigil (armodafinil) will likely include results of an FDA safety review for the firm’s other pending product, attention deficit hyperactivity disorder treatment Sparlon (modafinil).

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Approved labeling for Cephalon's follow-on compound armodafinil includes a bolded warning that a "serious rash requiring hospitalization and discontinuation of treatment" has been reported in patients using the product. Nuvigil was approved June 15 for excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift work sleep disorder. The bolded warning adds that Nuvigil is not approved for use by children for any indication. A similar warning will be added to labeling for Cephalon's first-generation product Provigil (modafinil). Rashes were seen in children taking the firm's Sparlon, which also has modafinil as its active ingredient, in studies for a potential attention deficit/hyperactivity disorder indication. Nuvigil had received an "approvable" letter in April 2006, with FDA requesting data on the rashes related to Sparlon (1Pharmaceutical Approvals Monthly May 2006, p. 19)...

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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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