Navigation Links
FDA accepts Labopharm's response for once-daily tramadol as complete Class 2 response
Date:7/17/2008

- FDA Assigns PDUFA Date of January 2, 2009 -

LAVAL, QC, July 17 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that the response that it submitted to the U.S. Food and Drug Administration (FDA) on July 2, 2008, including the additional analysis of existing data as suggested by the Agency, has been accepted as a complete, Class 2 response. The action date assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 2, 2009.

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid(R) technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 12 countries, including the five largest markets in Europe and Canada and is approved in 18 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distribution agreements in place for more than 50 markets globally.

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 an 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 in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world 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©2008 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Accepts Gentas NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
2. Partnering With MyPyramid: NUTRIKIDS Accepts the Challenge to Help Families Step Up to Healthier Living
3. AMEX Accepts Lorus Plan to Meet AMEXs Continued Listing Standards
4. Mike Huckabee Accepts Values Voter Presidential Debate
5. ev3 Inc. Accepts Resignation of Dr. John Simpson
6. Lieutenant Governor Catherine Baker Knoll Accepts Women in Government Presidential Leadership Award
7. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
8. Governor Rendell Accepts National Health Care Reform Pioneer Award
9. American Stock Exchange Accepts Encisions Plan to Regain Compliance
10. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
11. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2017)... ... June 23, 2017 , ... Yesterday, U.S. ... healthcare bill to repeal and replace the Affordable Care Act (ACA). Like the ... significant cuts to Medicaid, a public health insurance program for low-income children, pregnant ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own ... others prefer to read it, and some people don't like it at all. FindaTopDoc ... what they found: , Erotic literature can give readers a taste of their deepest, ...
(Date:6/23/2017)... ... ... 21 Middle East and South Asia Leaders Selected as Eisenhower Fellows ... civil society in 11 countries across the Middle East and South Asia to embark ... of knowledge and ideas with the leading minds in their fields. , For ...
(Date:6/23/2017)... ... 23, 2017 , ... Ulster University, Magee Campus in Northern Ireland is hosting ... pm to present to graduate students exciting new and innovative hope research based on ... by The Health Improvement Service of the Western Health & Social Care Trust (WHSCT) ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore ... Houston area with access to asset protection and financial planning services, is teaming ... at improving the lives of children with cancer and other chronic diseases. , ...
Breaking Medicine News(10 mins):
(Date:6/14/2017)... 2017  ivWatch LLC, a medical device company focused ... therapy, is pleased to announce it was the Bronze ... Supplies and Equipment at the 2017 Medical Design Excellence ... industry. The award was presented by Medical Device and ... in New York during MD&M ...
(Date:6/13/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a ... Food and Drug Administration (FDA) has notified the Company that ... Zhejiang, China manufacturing facility has been ... clearance of the Warning Letter related to our ... of the progress we have made in our ongoing quality ...
(Date:6/10/2017)... , June 9, 2017  Shane K. Burchfield, DPM, is recognized ... excellence as a Podiatrist in Alabama . ... Family First Foot Care. He brings over 20 years of experience, ... management and healthcare, to his role. ... Care, PC is pleased to welcome you to his ...
Breaking Medicine Technology: