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:10/2/2014)... Philadelphia, PA (PRWEB) October 02, 2014 ... winners of the 2014 BIG Awards for Business ... companies and organizations with a proprietary judging process ... from around the globe. , “The winners this ... said Russ Fordyce, Managing Director of the Business ...
(Date:10/2/2014)... Salamon HealthDay Reporter ... with a neurotic personality style and prolonged stress may ... research suggests. Tracking 800 women over nearly four ... anxious, jealous and moody -- which they defined as ... risk of developing Alzheimer,s compared to women scoring lowest ...
(Date:10/2/2014)... Steven Reinberg HealthDay Reporter ... to a major highway may raise your risk for high ... 5,000 postmenopausal women, those who lived within 109 yards of ... developing high blood pressure than women living at least half ... this study highlight the importance of our physical environment on ...
(Date:10/2/2014)... HealthDay Reporter WEDNESDAY, Oct. 1, ... Columbia now have a total of 500 confirmed cases of ... children since the summer, U.S. health officials reported Wednesday. ... recent weeks, but it,s not clear what role -- if ... Health officials are also trying to determine if the ...
(Date:10/1/2014)... more than 80 per cent of bowel cancers could ... that medicines called ,JAK inhibitors, halted tumour growth in ... in more than 80 per cent of bowel cancers. ... clinical trials, for diseases including rheumatoid arthritis, psoriasis, blood ... second-most common cancer in Australia with nearly 17,000 people ...
Breaking Medicine News(10 mins):Health News:Innovation Dominant Theme among 2014 Big Awards for Business Winners and Finalists 2Health News:Jealous, Moody Women May Face Higher Alzheimer's Risk, Study Says 2Health News:Jealous, Moody Women May Face Higher Alzheimer's Risk, Study Says 3Health News:Living Near a Highway May Be Bad for Your Blood Pressure 2Health News:Living Near a Highway May Be Bad for Your Blood Pressure 3Health News:42 States Reporting Respiratory Virus That Targets Kids 2Health News:42 States Reporting Respiratory Virus That Targets Kids 3Health News:Eighty percent of bowel cancers halted with existing medicines 2
... and British scientists have now found that it is helpful in ... warfare. , ... Manhasset, NY (Vocus) May 6, 2009 ... found that it is helpful in delaying the effects of ricin, ...
... May 6 Parishioners at Guardian Angels Catholic Church in ... shelf -- they actually grow it themselves. The project is ... by the Institute for Agriculture and Trade Policy (IATP) and ... Cross) that demonstrate a growing nationwide movement within the faith ...
... 6 Symmetry Medical Inc. (NYSE: SMA ), ... device industry and other medical markets, announced today that Brian ... Hite, Senior Vice President and Chief Financial Officer, are scheduled ... 2009 Healthcare Conference at the Palace Hotel in New York ...
... Mich., May 6 Perrigo Company (Nasdaq: ... Directors declared a quarterly dividend of $0.055 per share, ... on May 29, 2009. Perrigo Company is a leading ... (OTC) and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ...
... PA, 6 May 2009 Obstructive sleep apnea (OSA) ... in heart failure (HF) patients managed with beta-blockers and ... Journal of Cardiac Failure ( http://www.elsevier.com/locate/cardfail ), ... of Sleep Apnea in Patients with Heart Failure and ...
... lack of guidance and training provided for nurses involved in ... , Writing in the May issue of the Journal ... highlighted the need for an audit of current UK services ... , But they point out that the basic issues they ...
Cached Medicine News:Health News:Nicotine May Help Prevent Damage from Bioterrosim Toxin and Growth Factors in Heart Disease News from Molecular Medicine 2Health News:Report Finds Faith Organizations Building Community, Improving Health Through Healthy Foods 2Health News:Report Finds Faith Organizations Building Community, Improving Health Through Healthy Foods 3Health News:Report Finds Faith Organizations Building Community, Improving Health Through Healthy Foods 4Health News:Symmetry Medical to Present at Bank of America and Merrill Lynch 2009 Healthcare Conference 2Health News:Sleep apnea may not be closely linked to heart failure severity 2Health News:Nurses are assessing mothers with mental health issues despite lack of guidance and formal training 2Health News:Nurses are assessing mothers with mental health issues despite lack of guidance and formal training 3
(Date:10/1/2014)... 2014  Varian Medical Systems (NYSE: VAR ... the fourth quarter of fiscal year 2014 following the ... The news release will be followed by a teleconference ... The news release and a link to the conference ... at: www.varian.com/investor .  To access the teleconference call ...
(Date:10/1/2014)... Oct. 1, 2014 Quantum Materials Corp ... production of photoactive quantum dots for use in ... offering numerous advantages for solar power generation, the ... of quantum dots with which to develop thin ... from commercial utilization and acceptance. The company is ...
(Date:10/1/2014)... Calif. , Oct. 1, 2014 /PRNewswire/ ... ), a clinical-stage biopharmaceutical company focused on ... positive results from its 371 patient Phase ... with constipation-predominant irritable bowel syndrome (IBS-C).  Results ... clinically meaningful improvement in IBS-C symptoms for ...
Breaking Medicine Technology:Varian Medical Systems Schedules Fourth Quarter FY2014 News Release and Conference Call 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 3Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 2Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 3Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 4Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 5Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients 6
... Medical, Inc. announces the addition of the BioTech Medical ... to its ever expanding line of innovative ... goes by that our office doesn,t receive a call for ... BioTech Medical, Inc.  "We listened to our customers, and now, ...
... Md., July 18, 2011 MedImmune announced today ... Live, Intranasal) to influenza vaccine distributors who service ... MedImmune expects to provide approximately 15 ... spray flu vaccine for the 2011-2012 influenza season ...
Cached Medicine Technology:FluMist® (Influenza Vaccine Live, Intranasal) Begins Shipping for 2011-2012 Influenza Season 2FluMist® (Influenza Vaccine Live, Intranasal) Begins Shipping for 2011-2012 Influenza Season 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: