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Article: Cephalon Receives Approvable Letter to Market Sugar-Free Formulation of ACTIQ(R).
- Article from:
- PR Newswire
- Article date:
- March 25, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. 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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FRAZER, Pa., March 25 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) to market a new sugar-free formulation of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II].
ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Once approved, the sugar-free formulation will be marketed for the same indication using the same name. Studies in healthy volunteers demonstrated bioequivalency between the sugar-free and the ...