FDAnews Drug Daily Bulletin

DECISION DATE FOR CEPHALON'S ADHD DRUG DELAYED

May 4, 2006
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The FDA has pushed its decision date for Cephalon's new drug for the treatment of attention deficit hyperactivity syndrome by three months.

The decision on whether Sparlon (modafinil) can be sold in the U.S. will now be August 22. The announcement comes on the heels of Cephalon's recent announcement that it had submitted additional material to the FDA regarding a skin rash suffered by a child in a clinical trial that was initially suspected to be Stevens Johnson Syndrome (SJS). The company has stated the new information submitted to the FDA, based on consultations with the child's doctors and dermatology experts, supports its claim that the rash was not SJS.