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 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 U.S FDA's Formal Dispute Resolution process, the regulatory process for drug approval and the commercialization of the Company's products, if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.


'/>"/>
SOURCE Labopharm Inc.
Copyright©2007 PR Newswire.
All rights reserved

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:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Global Blood Therapeutics, ... company developing novel therapeutics for the treatment of ... announced the closing of its previously announced underwritten ... at the public offering price of $18.75 per ... were offered by GBT. GBT estimates net proceeds ...
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
Breaking Medicine Technology: