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Cephalon’s ADHD Drug Not Approved

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cephalon has received a non-approvable letter from the FDA regarding its sNDA for Sparlon Tablets, a proprietary dosage form of modafinil for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. In consideration of the FDA’s decision, the company has determined that it will not pursue further development of the drug. Modafinil is the active ingredient in Cephalon’s main drug, insomnia treatment Provigil.

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