|
|
Article: Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy.
- Article from:
- PR Newswire
- Article date:
- April 1, 2008
CopyrightCOPYRIGHT 2008 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)
|
- Company Believes That Continuing to Follow Dispute Resolution Process is the Most Expeditious Path to Final Approval -
LAVAL, QC, April 1 /PRNewswire-FirstCall/ -- Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has appealed the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level under the FDA's Formal Dispute Resolution process. Labopharm's continuation of the appeal process follows the completion of additional statistical analysis of existing data per the suggestion of Dr. John K. Jenkins, M.D., the FDA's Director for the Office of New Drugs, Center for Drug Evaluation and ...