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:1/23/2017)... ... January 23, 2017 , ... The Masters of Science ... evaluation leaders with decades of experience who remain current practitioners in the field. ... system, there is a renewed demand for versatile, data-driven leadership.The American University’s MS ...
(Date:1/23/2017)... ... January 23, 2017 , ... Moisture measurement is a ... method is paramount to success. Selecting an inappropriate measurement method can cause costly ... use the same equipment. Rare or expensive substances are wasted and production may ...
(Date:1/23/2017)... ... January 23, 2017 , ... Gynecology Associates of ... gynecological services for women of all ages. The staff of Gynecology ... of reproductive services from routine health screenings to diagnosing and treating female concerns ...
(Date:1/23/2017)... ... ... “Some Infallible Characteristics of Christ”: a fascinating and entrancing novel exploring the ... of published author, Rev. Dr. Robert W. Thomas, the third of seven siblings. He ... nineteen, a pastor for over fifteen years. He is a graduate of N.C. College ...
(Date:1/22/2017)... ... January 22, 2017 , ... Medical lab testing through hospitals and ... a simple test will take days to arrive to the end customer, having to ... access to their lab tests, bypassing the cost and delay of traditional means. Now ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... Jan 23, 2017 Research and Markets has announced ... Trends - Product - Forecast to 2025" report to their offering. ... Report Highlights: ... market trends to identify the investment opportunities Market forecasts ... Key market trends across the business segments, Regions and Countries ...
(Date:1/23/2017)... Jan. 23, 2017  Using Astute Medical,s ... risk for acute kidney injury (AKI) after open-heart ... care guidelines significantly improved outcomes by ... more than 33 percent, according to a ... Intensive Care Medicine. Experience ...
(Date:1/23/2017)... January 23, 2017 Ahead of today,s trading ... how they have fared at the close: Kite Pharma Inc. (NASDAQ: ... OVAS ), and Regeneron Pharmaceuticals Inc. (NASDAQ: ... were relative laggards on Friday, January 20 th , 2017, down ... research reports on these stocks now at: ...
Breaking Medicine Technology: