Sparlon User Fee Date Extended To August
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has extended the user fee date for Cephalon's attention deficit/hyperactivity disorder treatment Sparlon (modafinil) to Aug. 22, the company said April 24
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FDA has extended the user fee date for Cephalon's attention deficit/hyperactivity disorder treatment Sparlon (modafinil) to Aug. 22, the company said April 24. The delay is related to Cephalon's April 18 submission of new data regarding a possible case of Stevens Johnson Syndrome in a Phase III clinical trial. "The company formally submitted this new information to the FDA in support of its position that this case is not, in fact, SJS," Cephalon said. FDA's Psychopharmacologic Drugs Advisory Committee largely agreed in March that safety data presented by Cephalon was insufficient for approval (1 (Also see "Cephalon Sparlon Additional Pre-Approval Safety Study Recommended To Assess Skin Reaction Risk" - Pink Sheet, 23 Mar, 2006.)). Modafinil is currently marketed as Provigil to treat excessive sleepiness. |