RyzoltTreatment for Pain
Update: Ryzolt Now FDA Approved - December 30, 2008
Labopharm Receives FDA Response to Recent Appeal of Approvable Letter For Once-Daily Tramadol
FDA Proposes Additional Statistical Analysis of Existing Data as Means to Satisfy Agency's Requirements
LAVAL, QC, January 24, 2008 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. John K. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research, did not overturn the decision. However, Dr. Jenkins has suggested additional statistical analysis of existing data as a means to potentially satisfy the Agency's requirements. The statistical method proposed for the analysis is different from that previously requested by the FDA since the May 2007 Approvable Letter. Dr. Jenkins also recommended the Company meet with the Agency prior to any resubmission.
"We are encouraged by the FDA's recent communication and are currently evaluating the proposal outlined in the letter," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We look forward to potentially resolving the outstanding issues."
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become a fully integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process for drug approval and the commercialization of the Company's products, if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
CONTACT: At Labopharm, Mark D'Souza, Chief Financial Officer, Tel: (450)686-0207; At The Equicom Group, Jason Hogan, Media and Investor Relations,Tel: (416) 815-0700, ; French: Eric Bouchard, Tel:(514) 844-7997, firstname.lastname@example.org email@example.com
Ticker Symbol: (Toronto:DDS.),(NASDAQ-NMS:DDSS)
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Posted: January 2008
- Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain - December 31, 2008
- FDA Accepts Labopharm's Response for Once-Daily Tramadol as Complete Class 2 Response - July 17, 2008
- Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol - July 3, 2008
- Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product - June 30, 2008
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy - April 1, 2008
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol - October 15, 2007
- Labopharm Provides Update on U.S. Regulatory Process for Once-Daily Tramadol - September 25, 2007
- Labopharm Meets with FDA to Discuss Second Approvable Letter for Once-daily Tramadol - June 29, 2007
- Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol - June 1, 2007