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Article: Following FDA Panel, Cephalon Expects Provigil Label Expansion.(Cephalon's Provigil is effective)
- Article from:
- BIOWORLD Today
- Article date:
- September 26, 2003
- Author:
CopyrightCOPYRIGHT 2003 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Kim Coghill, Washington Editor
BETHESDA, Md. - An FDA advisory panel unanimously agreed that Cephalon Inc.'s wake-promoting agent, Provigil, is effective in treating excessive sleepiness associated with sleep apnea. And in a 6-2 vote, the panel said Cephalon's data supported the claim that Provigil is effective in the treatment of excessive sleepiness in patients with shift-worker sleep disorder.
But in a 4-4 vote, the Peripheral and Central Nervous System Drugs Advisory Committee Thursday was split when asked if Cephalon had proved Provigil's effectiveness in treating excessive sleepiness associated with "disorders of sleep and wakefulness," and ...