Navigation Links
Labopharm Initiates Regulatory Approval Process for Twice-Daily Tramadol-Acetaminophen in Europe
Date:12/17/2009

- Procedure Provides Efficient Mechanism to Pursue Approval in Multiple Jurisdictions -

LAVAL, QC, Dec. 17 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the Decentralized Procedure (DCP). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.

"Initiating the regulatory approval process in Europe builds on our recently established marketing partnership with Grunenthal GmbH," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "It is our intention to commercialize our twice-daily tramadol-acetaminophen formulation in key markets around the world. To this end, we are both preparing to submit additional regulatory applications in 2010 and pursuing marketing partners in key regions around the world."

In accordance with the DCP, Labopharm has submitted a marketing authorization application (MAA) with a Reference Member State (Iceland), which will provide an assessment of the MAA file to the Company's list of Concerned Member States. Labopharm is responsible for obtaining regulatory approval in most of the countries included in the distribution and supply agreement with Grunenthal and is seeking approval in those countries. The regulatory authorities of both Reference Member State and Concerned Member States will achieve consensus regarding approval of the product and all Member States grant national Marketing Authorisations based upon that consensus decision. The DCP is expected to take approximately one year to complete and national Marketing Authorizations will be provided thereafter.

The estimated Euro sales i
'/>"/>

SOURCE Labopharm Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

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. Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
9. Labopharm enters into licensing and distribution agreement for once-daily tramadol in Australia with iNova
10. Canadian Marketing and Sales Effort for Labopharms Once-Daily Tramadol Product to Expand Significantly
11. Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... August 01, 2014 As AndroGel lawsuits ... country, Ronald E. Johnson, Jr. has been appointed as ... and other testosterone medications. Since the Fall of 2013, ... have worked diligently to investigate and prosecute the claims ... and blood clots as a result of taking testosterone. ...
(Date:8/1/2014)... a cancer diagnosis may improve health outcomes for Asian-American ... a researcher at the University of Houston (UH). ... is the writing instruction. Otherwise, writing is just like ... can be therapeutic, but oftentimes we don,t get the ... said Qian Lu, assistant professor and director of the ...
(Date:8/1/2014)... August 01, 2014 Growing prevalence ... and healthcare reforms are boosting healthcare market growth, ... through discounts and increasing generic consumption is a ... 76.7 million in 2013, having grown at a ... 2008. The implementation of the Health Transformation Program ...
(Date:8/1/2014)... Hot off the presses after the announcement of ... World’s Best Awards by Travel + Leisure , The ... Relaxation Day (technically August 15). , The Lodge at ... help guests celebrate relaxation throughout the month of August. ... wellness to carve out time to relax and unwind. ...
(Date:8/1/2014)... 2014 The "Antimicrobial Coatings Market ... Zinc Oxide, Titanium Dioxide, and Zinc Omadine), Application ... Food & Beverages, Textiles, and others), & Geography ... Trends and Forecasts to 2018" analyzes the Antimicrobial ... and trends in the diverse geographical regions. , ...
Breaking Medicine News(10 mins):Health News:Ron Johnson Named Co-Lead Counsel in Lawsuits for Men Injured by AndroGel and Testosterone 2Health News:Expressive writing may help breast cancer survivors 2Health News:Expressive writing may help breast cancer survivors 3Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 2Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 3Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 4Health News:The Lodge at Woodloch Kicks Off National Relaxation Day with a Month Long Celebration 2Health News:The Lodge at Woodloch Kicks Off National Relaxation Day with a Month Long Celebration 3Health News:The Lodge at Woodloch Kicks Off National Relaxation Day with a Month Long Celebration 4Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 2Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 3Health News:Antimicrobial Coatings Market Projected to Reach $2.9 Billion by 2018 – Report by MarketsandMarkets 4
... General Hospital,became the first hospital in Palm Beach County ... Electronic Birth Registry (EBR) system,launched on August 8, Glades ... reducing the costs and processing time. Now,the staff at ... the,report, and get the required electronic signatures -- all ...
... ATSI ), manufacturer and marketer of state-of-the-art ... will present at the,2007 Thomas Weisel Partners Healthcare ... Company,s presentation is scheduled for Wednesday, September,5, 2007 ... and CEO of ATS,Medical, will present a review ...
... Matrixx Initiatives, Inc.,(Nasdaq: MTXX ), an over-the-counter healthcare ... "Better Ways to Get,Better(R)," will be presenting on September ... Conference. The Company will be presenting at 11:30 ... http://www.matrixxinc.com . Interested parties,should login 15 minutes prior ...
... in,health-related research grew by a modest 4.2% from 2005 ... health costs, according,to a report released today by Research!America. ... Science. The nation spent approximately $116 billion last ... and prevent disease and disability. This,represents a decrease relative ...
... in Italian study , , THURSDAY, Aug. 30 (HealthDay News) -- ... of dying in the next year compared to those who ... number of other studies have shown the benefits of using ... instance, the Italian study comes on the heels of a ...
... A drug that shuts down a critical cell-signaling pathway ... brain cancer successfully kills cancer stem cells thought to ... radiation therapy, a Johns Hopkins study shows. , In ... scientists blocked the signaling system, known as Hedgehog, with ...
Cached Medicine News:Health News:Glades General Hospital First in Palm Beach County to Provide On-Site Electronic Birth Registration 2Health News:Glades General Hospital First in Palm Beach County to Provide On-Site Electronic Birth Registration 3Health News:ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference 2Health News:Matrixx Initiatives, Inc. to Present at the Roth Capital Partners 2007 New York Conference 2Health News:U.S. Research Funding Continues to Flatten as U.S. Health Costs Climb - in August 31 Science 2Health News:Stopping Statins After Stroke Doubles Death Risk 2Health News:Stopping Statins After Stroke Doubles Death Risk 3Health News:Experimental anti-cancer drug made from corn lillies kills brain tumor stem cells 2Health News:Experimental anti-cancer drug made from corn lillies kills brain tumor stem cells 3
(Date:8/1/2014)... Research and Markets  has announced ... Testing Markets (Lab-Based, Professional POC, Home, Employment, Criminal ... http://photos.prnewswire.com/prnh/20130307/600769 ... in IVD testing with competitive participation by top ... criminal justice personnel, and sports use drug tests ...
(Date:8/1/2014)... 1, 2014 Aspire Technology Partners (Aspire) announced today ... from Cisco. This designation recognizes Aspire for delivering outstanding customer ... America . "Achieving exceptional results for our ... Harris , President and CEO of Aspire. "We are pleased ... Gold Star award and are proud to be part of ...
(Date:8/1/2014)... Medical, Inc. (Nasdaq: NXTM ), a leading manufacturer ... Burbank , Chief Executive Officer, and Mathew Towse , ... Annual Canaccord Genuity Growth Conference being held at the InterContinental ... 13 th at 4:30 p.m. ET.  A webcast of ... About NxStage Medical NxStage Medical, ...
Breaking Medicine Technology:Drugs of Abuse Testing Markets (Lab-Based, Professional POC, Home, Employment, Criminal Justice Markets) 2Aspire Technology Partners Recognized By Cisco For Excellence In Customer Satisfaction 2NxStage to Present at the 34th Annual Canaccord Genuity Growth Conference 2
... Mass. , Feb. 4 Recognizing that corporate ... they contain, Northern Light ( www.northernlight.com ) today announced that ... excess of $2 billion can be searched, analyzed ... been steadily increasing the number of market research sources integrated ...
... N.C. , Feb. 4 Gorbec Pharmaceutical ... prescription pharmaceutical products, is opening a GMP-compliant analytical laboratory ... expand Gorbec,s current services for analytical method development and ... its U.S. customer base as well as develop a ...
Cached Medicine Technology:Northern Light Surpasses $2 Billion Worth of Research Content Integrated Into SinglePoint Strategic Research Portals 2Northern Light Surpasses $2 Billion Worth of Research Content Integrated Into SinglePoint Strategic Research Portals 3Gorbec Pharmaceutical Services, Inc. Announces the Launch of Its GMP Analytical Laboratory in China 2
ELISA kit for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in serum...
ELISA kit for the quantitative determination of autoantibodies to thyroglobulin in serum....
... the most potent, naturally secreted estrogen and ... ovary [1]. In the ovary, estradiol is ... a less potent estrogen derived from androstenedione. ... body tissues. In men, small amounts of ...
... troponin I (cTnI) has been useful in ... Emergency Departments (ED) with chest pain. 18-20 ... when blood levels of sensitive and specific ... isoenzyme of creatine kinase (CK-MB), and myoglobin, ...
Medicine Products: