Cephalon Sparlon For ADHD To Get Psychopharm Committee Review
This article was originally published in The Pink Sheet Daily
Executive Summary
The March 23 review of the new indication for modafinil, currently marketed as Provigil for narcolepsy, will likely focus on safety differences compared to other ADHD drugs.
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Incidence of events with Sparlon is higher than for placebo but exposure in patients is also greater, FDA summary of clinical adverse events states.
Cephalon Looks To Q2 For Launch Of Sparlon
Cephalon has pushed back the anticipated launch of its attention deficit/ hyperactivity disorder drug Sparlon (modafinil) from Q1 until the second quarter, pending the outcome of a review by FDA's Psychopharmacologic Drugs Advisory Committee March 23