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FDA Rejects Sparlon Application

FRAZER, Pa., Aug. 9 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the company's supplemental new drug application (sNDA) for modafinil (Sparlon) tablets [C-IV], a proprietary dosage form of modafinil for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents, is not approvable. In consideration of the FDA's decision, the company has determined that it will not pursue further development of Sparlon.

"Obviously, we are extremely disappointed and surprised that the agency disagreed with the opinions of our experts, which were based on photographic and other evidence concerning a single suspected case of Stevens Johnson syndrome," said Frank Baldino, Jr., Ph.D., Chairman and CEO.

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