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Cephalon signals possible Nuvigil delay

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cephalon plans to submit additional information to its pending Nuvigil (armodafinil) NDA "in the next few weeks," the company says Dec. 7. The submission could be considered a major amendment, resulting in an extension of a Dec. 31 user fee goal. FDA previously extended the Nuvigil user fee date when a case of serious rash in a child in trials of Sparlon (modafinil) for ADHD led to a "not approvable" letter and withdrawal of that drug's NDA. The company views the potential upcoming delay as "an important opportunity to ensure that the final label for Nuvigil reflects the actual medical condition of this child" in the Sparlon program; FDA suspected the rash to be Stevens-Johnson syndrome, a diagnosis Cephalon disputes. The proposed Nuvigil indication for excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/hyperpnoea syndrome and shift-work sleep disorder does not include children...

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