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Article: CEPHALON'S PROVIGIL RECEIVES APPROVAL FOR EXPANDED LABEL.
- Article from:
- BIOWORLD Today
- Article date:
- October 22, 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
Cephalon Inc. received FDA clearance to expand the Provigil label to include use in improving wakefulness in people with excessive sleepiness associated with shift-work sleep disorder and in patients with obstructive sleep apnea.
The company expects to launch the new indications during the first quarter of 2004.
"We look forward to finalizing the process and receiving FDA approval," Paul Blake, Cephalon's senior vice president of clinical research and regulatory affairs, said in a prepared statement. "We expect precise labeling language to be decided by year end, which keeps us on track to launch the ...