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FDA Delays Review of Modafinil in Attention Deficit/Hyperactivity Disorder

FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that the United States Food and Drug Administration (FDA) has extended the action date for its review of the Supplemental New Drug Application for SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents to August 22, 2006.

On April 18, 2006, the company announced that it had submitted new information to the FDA related to a suspected case of Stevens-Johnson syndrome ("SJS"), a rare but serious skin rash condition, in one child participating in a Phase 3 clinical trial. This information reflects discussions with the treating physicians, consultation with leading dermatology experts and informal discussions with the FDA. The company formally submitted this new information to the FDA in support of its position that this case is not, in fact, SJS.

"We are very pleased that the FDA has decided to review this new information very carefully, and hope that it will provide a basis for the approval of SPARLON," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations. "We anticipate further discussions with the FDA in the coming weeks."

Source: Cephalon, Inc.

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