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Article: Cephalon Files Supplemental New Drug Application for Sugar-Free Formulation of ACTIQ.
- Article from:
- PR Newswire
- Article date:
- December 1, 2004
CopyrightCOPYRIGHT 2004 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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Cephalon, Inc. announced today that it has filed a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration requesting marketing approval of a sugar-free formulation of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II].
The currently-marketed formulation of ACTIQ is approved by the FDA 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. If approved, the sugar-free formulation of ACTIQ will be marketed for the same indication.
"We developed this new formulation to meet both physician and ...