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...