Navigation Links
Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
Date:11/21/2007

LAVAL, QC, Nov. 21 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its appeal of the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research has not overturned the decision in the Agency's Approvable Letter of May 2007.

Labopharm plans to appeal the matter to the next supervisory level at the FDA in the coming weeks.

Labopharm initiated the Formal Dispute Resolution process in October of this year after receiving an Approvable Letter from the FDA for its once-daily formulation of tramadol in May.

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. For more information, please visit http://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.


'/>"/>
SOURCE Labopharm Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
2. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
3. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
4. Labopharm appeals FDAs decision on once-daily tramadol
5. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
6. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
7. Labopharm Reports Results for Third Quarter Fiscal 2007
8. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
9. DaVita Receives Civil Complaint
10. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
11. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , ... December 02, 2016 , ... "Pro3rd Accents Volume ... editors to create versatile lower third titles with just a few clicks of the ... Volume 2 includes 30 lower third animations. Choose from various styles with accented animations, ...
(Date:12/2/2016)... ... December 02, 2016 , ... Today CloudMine, a ... applications, was named the best Sales Team of 2016 as part of the ... today by the Software & Information Industry Association (SIIA), the principal trade association ...
(Date:11/30/2016)... Boston, Massachusetts (PRWEB) , ... November 30, 2016 ... ... is proud to announce that we have been designated as a Cigna Infertility ... meet or exceed rigorous performance standards. , “It’s an honor to be ...
(Date:11/30/2016)... ... November 30, 2016 , ... Standard ... 75, an annual ranking and recognition of the largest closely held companies headquartered ... ranked from 2008-2016. In addition, Standard Process was awarded the Talent Award for ...
(Date:11/30/2016)... ... November 30, 2016 , ... ... workers have been a focus of public policymakers and system stakeholders in many ... (WCRI) released its Medical Price Index for Workers’ Compensation, Eighth Edition (MPI-WC) ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... NEW YORK , December 2, 2016 ... Extremity Braces & Support) is Expected to Gain a Significant ... Prone to Orthopedic Ailments  ... , , According ... Market Study on Medical Implants Sterile Packaging: Clamshell Product Type ...
(Date:12/2/2016)... 2016   CytoSorbents Corporation (NASDAQ: CTSO ... Union approved CytoSorb ® cytokine adsorber to treat ... announced that Dr. Phillip Chan , Chief Executive ... Micro Main Event investor conference held from December ... Sunset Boulevard Hotel in Los Angeles, California ...
(Date:12/2/2016)... , December 2, 2016 On Thursday, ... 1.36%; the Dow Jones Industrial Average edged 0.36% higher, to ... down 0.35%. Losses were broad based as six out of ... initiated research reports on the following Services equities: Myriad Genetics ... QGEN ), INC Research Holdings Inc. (NASDAQ: ...
Breaking Medicine Technology: