Navigation Links
FDA accepts Labopharm's response for once-daily tramadol as complete Class 2 response

- 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

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:
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the ... 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the ... Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention Center ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... mental health and wellness consultation, has collaborated with Women’s Web – an ... reader’s queries on topics on mental and emotional well-being relationship, life balance, ...
(Date:11/25/2015)... Ill. (PRWEB) , ... November 25, 2015 , ... ... and potentially more aggressive than those found on mammography, according to a study ... findings of additional cancers not seen on mammography may necessitate a change in ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... gatherings where preparing the perfect dish and pleasing the palates of attendees is ... or bringing a dish to a seasonal get-together, give these recipes a try ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... companies, has been recognized once again for its stellar workplace culture with the ... Work.” , Medical Solutions’ Cincinnati office was named a finalist in ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... -- The total global healthcare industry is expected to grow at ... America has the highest projected growth at 12.7%, ... ), is second with growth projected at 11.5%. ... expenditure. In 2013-2014, total government funded healthcare was nearly 68%. ... 41.2% in 2013-2014. In real terms, out of pocket expenditure ...
(Date:11/25/2015)... WOODBURY, N.Y. , Nov. 25, 2015  Linden ... access and optimizing treatment outcomes for patients suffering from ... its request for a Temporary Restraining Order (TRO) enjoining ... between the two companies. --> ... aggressively pursuing all of its legal options. ...
(Date:11/25/2015)... USA , Inc., a leader in ... accuracy of its blood glucose meter systems. Last week ... Cardiovascular Disease in Los Angeles , ... 01 meter and the Assure ® Prism multi-user ... measure glucose levels in blood is essential for people ...
Breaking Medicine Technology: