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:4/17/2014)... potential to ward off depression among retirees, particularly among ... in The Journals of Gerontology, Series B: ... article " Internet Use and Depression Among Retired Older ... the authors report that Internet use reduced the probability ... study sample. , Late-life depression affects between 5 ...
(Date:4/17/2014)... Population Council scientists and their partners have found that ... prevent the transmission of multiple sexually transmitted infections (STIs) ... herpes simplex virus 2 (HSV-2), and human papillomavirus (HPV). ... the gel is effective against multiple strains of HIV, ... against all three viruses of at least eight hours ...
(Date:4/17/2014)... April 17, 2014 Meaningful long-term survival ... cancer of the abdomen when treated with cytoreductive ... to a first-of-its-size analysis by physicians at Wake ... has the largest reported, single-center experience with cytoreductive ... Levine, M.D., and analysis of 20 years, worth ...
(Date:4/17/2014)... is less than 40 years away from a food ... governments, according to a top scientist at the U.S. ... human history, food production will be limited on a ... energy," said Dr. Fred Davies, senior science advisor for ... become as politically destabilizing by 2050 as energy issues ...
(Date:4/17/2014)... 94 per cent of Canadians surveyed said they would ... a specific number of genetic conditions, only 80 per ... screening that would sequence their newborns, genomes.,Most newborns in ... first day or two of life in which a ... and tested for about five to 54 conditions, depending ...
Breaking Medicine News(10 mins):Health News:Internet use may cut retirees' depression 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:20 years of data shows treatment technique improvement for advanced abdominal cancer 2Health News:Food shortages could be most critical world issue by mid-century 2Health News:Researcher looks at public perceptions around newborn testing 2Health News:Researcher looks at public perceptions around newborn testing 3
... Andhra women have financed the bypass surgery of a fisherwoman ... to their efforts, B. Hemavati, 35, wife of a fisherman ... operation at the Tirupati-based Sri Venkateswara Institute of Medical Sciences ... Godavari district, was diagnosed with a heart ailment that doctors ...
... computerized tomography (CBCT) is increasingly becoming a potent tool ... ,J. Martin Palomo and Mark Hans from the department ... of Dental Medicine and C.H. Kau and S. Richmond ... at the University of Wales' College of Medicine have ...
... identified by the Oregon National Primate Research Center at ... to control stem cells becoming other brain cells.// New ... and brain injury as a result of continued research. ... early stages before birth, which become glial cells in ...
... to the role religion plays in a patient's life positively ... for female medicos and no, for male medicos.// ... of the Southern Medical Journal, patients want their physicians to ... to discuss religious issues with them, especially if they are ...
... scientist at Schepens Eye Research Institute (SERI) found that ... television watching more enjoyable to the visually impaired. // ... develop an electronic device to help millions suffering eye ... include those suffering from macular degeneration, diabetic retinopathy and ...
... Zealand government plans to contain it. ,They are preparing ... It will be in multiple waves and will extend up to ... does not have facilities to // tackle such situations (pandemic). ... acute disasters. ,But in this case people are not ...
Cached Medicine News:Health News:Poor Andhra Women Enable Bypass Surgery Paying 50 Paise Each 2Health News:New Computerized Imaging Systems Help In Better Dental Treatment Planning 2Health News:Religious sensitivity of medicos gender-dependent 2Health News:Visually impaired prefer specially enhanced TV 2Health News:Visually impaired prefer specially enhanced TV 3
(Date:1/15/2014)... , Jan. 15, 2014 The Cadence Fitness ... Fitness Center by the Medical Fitness Association, a non-profit ... achieve their full potential. The Cadence Fitness & Health ... western suburbs and second in the Chicagoland area. ...
(Date:1/15/2014)... Jan. 15, 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... tender offer by its indirect wholly-owned subsidiary, Sapphire Subsidiary ... common stock of Solta Medical, Inc. (NASDAQ: ...
(Date:1/15/2014)... 2014  A novel wearable injector slightly larger than an Oreo ... to self-inject prescription drugs in the large doses required to ... autoimmune deficiencies, and genetic disorders.  An emerging ... 2018, according to analysts.   Many of these drugs will require ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2
... Chiltern International Limited (Chiltern), a global contract research organization ... of their successful collaboration in Drug Phototoxicity. ... using a validated and regulatory accepted in vivo ... phototoxicity. The history of this collaboration can be traced ...
... 2011 Glenveigh Medical, LLC and Monica Healthcare Limited ... the United States as well as US territories and ... system. The system recently received FDA regulatory clearance for ... name Beacon by Monica™ , the wireless fetal ...
Cached Medicine Technology:Chiltern - Spectratox Drug Photoxicity Collaboration Celebrates 25 Years 2Chiltern - Spectratox Drug Photoxicity Collaboration Celebrates 25 Years 3Glenveigh Medical and Monica Healthcare Announce Distribution Agreement for Groundbreaking FDA Cleared Wireless Fetal Monitoring System 2
Excellent multi purpose agarose Nuclease-free, Gel point (1.5%): 36 1.5 C, EEO: 0.05-0.13 Gel strength (1%): > 1200 g/cm 2 ....
... NuSieve 3:1 Agarose is a molecular biology grade, ... for fine resolution of small DNA, RNA, and ... enhance the speed of gel processing and blotting. ... resolution of DNA fragments up to 1,000 bp, ...
... standard gelling temperature, high gel strength agarose ... bp. This Genetic Technology Grade™ (GTG) agarose ... DNA recovered from SeaKem GTG Agarose gels ... GTG Agarose is extensively performance tested to ...
... gel strength, high electrophoretic mobility, and ... is the superior choice for CHEF ... easy to handle at concentrations as ... run times. Low background staining also ...
Medicine Products: