Navigation Links
Labopharm appeals FDA's decision on once-daily tramadol
Date:10/15/2007

LAVAL, QC, Oct. 15 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has initiated the U.S. Food and Drug Administration (FDA)'s Formal Dispute Resolution process, appealing the Agency's decision regarding the Company's once-daily formulation of tramadol. Labopharm received a second Approvable Letter from the FDA for its once-daily formulation of tramadol in May of this year. The Company firmly believes it has met the statutory standards for approval of its once-daily tramadol formulation.

About the FDA's Formal Dispute Resolution Process

FDA regulations provide 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 a fully integrated, international, specialty pharmaceutical company wit
'/>"/>

SOURCE Labopharm Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Kalam Appeals to Eradicate Hearing Disability
2. UNAIDS Chief Appeals for Projects to Battle AIDS/HIV
3. Man Appeals to President to Save His Ailing Son
4. Appeals Against The New Resolution By NICE Increases
5. Unicef Appeals To Prioritize Children In Fight Against AIDs
6. Swiss Group Appeals Invocation of Euthanasia Option For The Severely Depressed
7. Fidel Castro Appeals for Investment in Health Rather Than in Arms
8. FDAs Failure Urges It to Reassess Its Policies
9. FDAs Gesture for Firm Manufacturing Drug for Cushings Syndrome
10. People suffering from Alzheimer’s: can they take decisions about their treatment
11. Decision making made easier
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Dallas, TX (PRWEB) January 22, 2015 ... the issue of experience and person-centeredness in the long-term ... moving towards action across the continuum. The paper, “The ... the Continuum,” engages perspectives and practices of the patient, ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Autocarinsurancebest.com has released ... purchasing a commercial auto insurance policy . , Auto ... their vehicles. It is no longer necessary to call an ... are now available online on a single website: http://autocarinsurancebest.com/ ...
(Date:1/22/2015)... Carinsurancesavings.biz has released a new blog post presenting ... . , Purchasing an accidental death and dismemberment rider ... type of rider provides benefits if the insured dies in ... lesser form of life insurance. , AD&D is not ...
(Date:1/22/2015)... NY (PRWEB) January 22, 2015 ... of Sports Medicine flagship journal Medicine & Science ... L-Citrulline before exercise may help reduce gastrointestinal (GI) ... 1 , Participants in the double-blind, placebo-controlled ...
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy ... its highest annual revenues in the past three years. Today, ... wedding dresses. , According to the sales manager of the ... for them in 2015. This point can be reflected on ...
Breaking Medicine News(10 mins):Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2
... health insurance quote engine Whataquote.com adds free quotes for guaranteed issue ... to pre-existing conditions or cannot afford a major medical policy. ... ... health insurance quote engine Whataquote.com announces the addition of a new ...
... MINNEAPOLIS / ST. PAUL (April 1, 2009) It ... drug addiction has a similar effect on the compulsive behavior ... to new research at the University of Minnesota., The Medical ... 25 men and women ages 17-75, who spent an average ...
... national public health organizations joined the Steelworkers Union ... a thorough investigation and action to alleviate the ... chronic diseases, which may be associated with ... )This call for government action accompanies release ...
... March 31 The Kroger Co. said today it is recalling ... date of SEP-25-09 sold in Kroger stores in Southwestern Ohio, including ... the product may be contaminated with Salmonella. No illnesses have been ... item: , , , ...
... healthcare facilities are providing patients with safe, reliable care using affordable ... ... 2009 -- Faced with an unrelenting economic outlook, many surgery centers ... refurbished medical equipment from DRE, a medical and surgical equipment ...
... Corporation (NYSE: BSX ) announced today that the ... in the Company,s stent litigation with Johnson and Johnson (J&J). ... that JNJ,s Bx Velocity and Cypher Stent Systems infringe Boston ... Appeals Court reversed the District Court with respect to the ...
Cached Medicine News:Health News:Free Quotes for Health Insurance Anyone Can Qualify For 2Health News:Free Quotes for Health Insurance Anyone Can Qualify For 3Health News:Joplin Citizens and Health Organizations Call on Missouri Gov. Nixon for Study, Action on High Incidence of Birth Defects and Chronic Diseases in Community 2Health News:Healthcare Facilities Focusing on Affordability, Dependability 2Health News:Healthcare Facilities Focusing on Affordability, Dependability 3Health News:Appeals Court Affirms That J&J Stents Infringe Boston Scientific Patent; Claims Against TAXUS Liberte Dismissed 2Health News:Appeals Court Affirms That J&J Stents Infringe Boston Scientific Patent; Claims Against TAXUS Liberte Dismissed 3
(Date:1/23/2015)... ANGELES , Jan. 23, 2015 A lot of ... best methods for treating  certain illnesses, injuries, or conditions. As ... replace previous treatment methods with ones that they consider to ... hernias, there is not one textbook method of treatment that ...
(Date:1/23/2015)... Jan. 23, 2015  The Partnership to Fight Chronic Disease (PFCD) released ... care leaders and a new study analyzing the impact of increased ... a nationwide coalition working to educate policy makers and the public ... Capitol was focused on how the Iowa ...
(Date:1/23/2015)... 2015  Northwest Biotherapeutics, Inc. (NASDAQ: NWBO )("NW Bio"), ... operable and inoperable solid tumor cancers, announced today that CEO ... Annual Phacilitate Immunotherapy Forum in Washington D.C. ... take place on January 26 at 10:30 a.m. EST at ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2New research shows Iowa health exchange would benefit from improvements 2New research shows Iowa health exchange would benefit from improvements 3NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 3
... , , PHOENIX, ... published two new publications on hormone therapies and their effects on ... , Cardiovascular disease caused by atherosclerosis, or the build-up ... of American women--40% of total deaths--and the rate of mortality is ...
... OMER and MIGDAL HA,EMEK, Israel, August 3 ,Medigus ... visualization,medical devices, and Tower Semiconductor, Ltd. (Nasdaq: ... today announced successful,sampling of a new CMOS imager that ... its new medical devices camera; the smallest of its,kind ...
Cached Medicine Technology:TWO NEW KLRI PEER-REVIEWED PUBLICATIONS: Hormone Therapy May Reduce Atherosclerosis in Women Close to Menopause; Growth Hormone May Increase Risk of Diabetes, Improve Lipid Profile in Men 2TWO NEW KLRI PEER-REVIEWED PUBLICATIONS: Hormone Therapy May Reduce Atherosclerosis in Women Close to Menopause; Growth Hormone May Increase Risk of Diabetes, Improve Lipid Profile in Men 3Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor 2Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor 3Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor 4
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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: