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Sparlon review

Executive Summary

Cephalon's attention deficit/hyperactivity disorder drug Sparlon will be reviewed by FDA's Psychopharmacologic Drugs Advisory Committee on March 23. The meeting will follow two advisory committee reviews on the safety of ADHD drugs in February and March. Sparlon contains the same active ingredient as Cephalon's Provigil, which is approved for narcolepsy. The modafinil sNDA for ADHD in children and adolescents ages 6-17 was deemed "approvable" by FDA on Oct. 20 pending resolution of labeling issues (1"The Pink Sheet" Jan. 2, 2006, p. 12). The meeting will be held at the Hilton in Gaithersburg, Md. beginning at 8 a.m. [Editor's note: To 2watch a webcastor order a video/DVD of this or any other meeting, visit FDAAdvisoryCommittee.com]...

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