Cephalon gets extended action date for Sparlon

By Elaine Rigoli

Tampa, Fla., April 24 - Cephalon, Inc. announced Monday that the Food and Drug Administration has extended the action date for its review of the supplemental New Drug Application for Sparlon (modafinil) tablets for the treatment of attention-deficit/hyperactivity disorder in children and adolescents to Aug. 22, 2006.

On April 18, the company announced that it had 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 3 clinical trial, according to a news release.

However, the company formally submitted new information to the FDA alleging that this case is not Stevens-Johnson syndrome.

"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 Paul Blake, executive vice president, worldwide medical and regulatory operations, in a statement.

"We anticipate further discussions with the FDA in the coming weeks."

Based in Frazer, Pa., Cephalon is a biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

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