New Nuvigil user fee date is late March
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cephalon expects approval of its wakefulness agent Nuvigil (armodafinil) in March, its new user feel goal, after submitting data in December regarding a child with serious rash in trials of the related compound Sparlon (modafinil). The rash case led to Cephalon's withdrawal of Sparlon, its modafinil NDA for ADHD; modafinil is marketed as Provigil for wakefulness indications. Like Provigil, Nuvigil - a single isomer of modafinil - is not intended for children (1Pharmaceutical Approvals Monthly December 2006, p. 2). "We're a little surprised that they seem to want more information on what to call this [rash] and where to place it in the Nuvigil label," CEO Frank Baldino said, but "we're happy to comply." If Nuvigil is approved "in March, as I expect…I could probably launch in two weeks, but I probably won't," he added. "Provigil is enjoying a lot of growth….I may not want to put [Nuvigil] on the market until 2009, but it's important to get it approved." Nuvigil is protected by a composition of matter patent expiring Dec. 18, 2023...
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Cephalon signals possible Nuvigil delay
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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