Navigation Links
Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
Date:4/1/2008

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 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 FDA's Formal Dispute Resolution process, the outcomes of clinical trials, the regulatory process
'/>"/>

SOURCE Labopharm Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Acetaminophen
2. Labopharms Once-Daily Tramadol Approved in South Korea and Australia
3. Labopharm to host conference call Thursday, February 21, 2008 at 8:30 a.m. (ET)
4. Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone
5. Canadian Marketing and Sales Effort for Labopharms Once-Daily Tramadol Product to Expand Significantly
6. Labopharm enters into licensing and distribution agreement for once-daily tramadol in Australia with iNova
7. Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
8. Labopharm Reports Results for Third Quarter Fiscal 2007
9. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
10. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
11. Labopharm appeals FDAs decision on once-daily tramadol
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)... Texas (PRWEB) July 13, 2014 Epidemiologists ... aGVHD in the 6MM, from 8,062 diagnosed incident cases ... at an Annual Growth Rate (AGR) of 4.35%, during ... the highest number of diagnosed incident cases of aGVHD ... Spain will have the lowest number of diagnosed incident ...
(Date:7/13/2014)... According to the Kidney Disease Solution book review recently updated ... what to do to eliminate the root cause of ... review that readers can easily learn what foods to avoid ... Vkool also informs in its Kidney Disease Solution review that ... naturally. The book consists of a collection of natural remedies ...
(Date:7/13/2014)... 2014 Celebrity fitness trainer and former ... promotional partnership with Aqua Health Labs for their flagship ... supplement . The collaboration was recently announced live on ... trainer , actor, model, and a two time World ... celebrities, he has prepared stars including Demi Moore, Hilary ...
(Date:7/13/2014)... If Dr. Lawrence Power has his way, the innovative ... http://www.HealthYourself101.com will expand people’s understanding of the causes, consequences, ... out to provide a health education platform on this modern ... say it? – entertaining to dig into and learn from. ... remote learner – the solitary individual signing on from a ...
(Date:7/13/2014)... Recently, iFitDress.com, one of the most popular suppliers of ... a new selection of beautiful evening dresses ... promotion for these evening gowns. Now, everybody can enjoy ... thousands of graceful gowns in its online store. Most ... Italy and many other countries. They are highly appreciated ...
Breaking Medicine News(10 mins):Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 2Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 3Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 3Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 4Health News:New and Beautiful Evening Dresses Unveiled by iFitDress.com 2
... cause of death in the Intensive Care Unit (ICU) is ... central nervous system// and cardiovascular system. The study also revealed ... who are out of the ICU but still in hospital ... ,This study is published in the journal Critical Care. Investigation ...
... were performed, much has been learned about illegal transplants of ... are quite common in countries like India and China ... Africa, people sell their kidneys to foreigners. ,Much ... news was in Jan 2006, about an Indian who died ...
... feelings either way has been brought up by senior doctors ... mercy killing of// new borns who are severely disabled. ... this recommendation as the solution to the incresing numbers of ... alive because of the advanced technology in the medical ...
... injuries like low back pain and disc disorder now ... gas could bring better results than conventional// surgery. ... started gaining ground in western countries, according to senior ... subject., ,'Ozonucleolysis or ozone discectomy for curing spinal ...
... charged with cheating the organisation he earlier worked for has ... Cell of Delhi Police arrested Alok Tomar, a former editor ... ,Tomar was arrested after he flew into the capital ... Deputy Commissioner of Police Alok Kumar. ,Kumar said ...
... rabies, a farmer's extended family in Bihar has to now ... as they had drunk the milk of the infected cows. ... in Dakhin Tola in Purnea district, were bitten by a ... weeks, according to local media reports here. ,The farmer's ...
Cached Medicine News:Health News:Consider Euthanasia For Severely Disabled Babies, College Tells Doctors 2Health News:Ozone Treatment - A Good Alternative For Spinal Injury 2
(Date:7/11/2014)... -- Neurelis, Inc. ("Neurelis") today announced an agreement with ... by Biotie to purchase Neurelis, clearing the way for ... for pediatric and adult epilepsy patients who experience acute ... has advanced the development program for NRL-1 and worked ... required for NDA submission to the FDA.  Given the ...
(Date:7/10/2014)... -- Integrated Silicon Solution, Inc. (Nasdaq: ISSI ... solutions, today announced that it will host its earnings ... a.m. Pacific Time (10:00 a.m. Eastern Time) to discuss ... quarter ended June 30, 2014. To access ... a.m. Pacific time on July 24, 2014.  The participant ...
(Date:7/10/2014)... --  Ventana Medical Systems, Inc.  (Ventana), a member of ... an agreement with Merck KGaA, Darmstadt, Germany ... the United States and ... division on the development and commercialization of a companion ... diagnostic assays. In alignment with Merck KGaA,s strategic approach ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 2Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 3
... Takeda Pharmaceuticals International, Inc., a wholly-owned subsidiary ... its Pharmaceutical Development Division has entered into strategic ... and Quintiles, two of the world,s largest full-service ... the agreements, Covance and Quintiles will work in ...
... Viral Genetics, Inc. (Pink Sheets: VRAL ) ... and Advisor Mr. Richard Gerstner will receive the Lauren F. ... award presentation is set for the Illusions of Lyme Gala, ... being recognized for her research on Targeted Peptide treatment for ...
Cached Medicine Technology:Takeda Enters Into Global Strategic Partnerships With Covance and Quintiles 2Viral Genetics' Researcher and Advisor Set to Share Award 2Viral Genetics' Researcher and Advisor Set to Share Award 3