FDA EXTENDS SNDA REVIEW DATE FOR SPARLON TABLETS

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.