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:12/9/2016)... Rockville, MD (PRWEB) , ... December 09, 2016 ... ... need for counseling and aural rehabilitation—provided by audiologists—to remain a critical part of ... U.S. Food and Drug Administration (FDA) announced this week that, starting ...
(Date:12/9/2016)... ... December 09, 2016 , ... Cellairis is a worldwide mobile ... on iPhone , iPad and Samsung Galaxy devices with premium parts ... in order to maximize convenience and accessibility for customers. While customers do their shopping, ...
(Date:12/9/2016)... ... , ... "I have gout, and I wanted to treat it naturally," said ... to relieve gout and pain caused by varicose veins. I drank it every morning ... relieved what VA doctors called the worst sinusitis case they'd seen and relieved gas, ...
(Date:12/9/2016)... CA (PRWEB) , ... December 09, 2016 , ... ... young adults, celebrated its 10th anniversary with the grand opening of the Sober ... The successful event spanned two days, December 2-3, and was attended by an ...
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... Mediaplanet today ... for organ transplantation while encouraging readers to sign up as an organ donor for ... organ transplant. , An organ donor can save up to 8 saves through ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016  Eli Lilly and Company ... of its phase 3 EXPEDITION3 trial at the 9 ... As previously disclosed, solanezumab did not meet the primary ... solanezumab initiated in people with mild dementia due to ... submissions for solanezumab for the treatment of mild dementia ...
(Date:12/8/2016)... Mederi Therapeutics Inc . anunciou aprovação regulatória, pela CFDA, e lançamento de ... refluxo gastroesofágico (DRGE). Foto -  http://photos.prnewswire.com/prnh/20161207/446903 ... ... procedure performed and broadcast during the Chinese Congress of Digestive Endoscopy, by Professor ... , , ...
(Date:12/8/2016)... , Dec. 8, 2016  Pennsylvania Physician General ... Drug and Alcohol Programs Gary Tennis ... medications, known as benzodiazepines, developed with the help ... are medications that are frequently prescribed for anxiety ... are used with opioid pain medications, benzodiazepines pose ...
Breaking Medicine Technology: