FDA EXTENDS SNDA REVIEW DATE FOR SPARLON TABLETS

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Cephalon has reported that the FDA has extended the action date for its review of the company's supplemental new drug application for Sparlon tablets for the treatment of attention-deficit/hyperactivity disorder in children and adolescents. The new application review date is Aug. 22, 2006.

The extension comes after Cephalon submitted new information to the FDA related to a suspected case of Stevens-Johnson syndrome -- a rare but serious skin rash condition -- in one child participating in a Phase III clinical trial of the drug.