RyzoltTreatment for Pain
Update: Ryzolt Now FDA Approved - December 30, 2008
Labopharm Appeals FDA's Decision on Once-Daily Tramadol
LAVAL, QC, October 15, 2007 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has initiated the U.S. Food and Drug Administration (FDA)'s Formal Dispute Resolution process, appealing the Agency's decision regarding the Company's once-daily formulation of tramadol. Labopharm received a second Approvable Letter from the FDA for its once-daily formulation of tramadol in May of this year. The Company firmly believes it has met the statutory standards for approval of its once-daily tramadol formulation.
About the FDA's Formal Dispute Resolution Process
FDA regulations provide a mechanism for those seeking regulatory approval of a drug product through a New Drug Application (NDA) to obtain formal review of any Agency decision through a Formal Dispute Resolution process by raising the matter with the supervisor of the employee who made the decision. If the issue is not resolved at the primary supervisory level, the applicant may request that the matter be reviewed at the next higher supervisory level. This process may continue through the Agency's chain of command, through the Centers to the Commissioner of Food and Drugs. The Formal Dispute Resolution process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, new drug review, generic drug review, and post-marketing oversight processes.
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.
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 U.S FDA's Formal Dispute Resolution process, 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.
Posted: October 2007
- 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-DailyTramadol Product - June 30, 2008
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol to NextSupervisory Level After Additional Analysis Supports Efficacy - April 1, 2008
- Labopharm Receives FDA Response to Recent Appeal of Approvable Letter For Once-Daily Tramadol - January 24, 2008
- Labopharm Provides Update on U.S. Regulatory Process for Once-DailyTramadol - September 25, 2007
- Labopharm Meets with FDA to Discuss Second Approvable Letter forOnce-daily Tramadol - June 29, 2007
- Labopharm Receives Second Approvable Letter from FDA for Once-DailyTramadol - June 1, 2007