Navigation Links
Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
Date:11/21/2007

LAVAL, QC, Nov. 21 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its appeal of the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research has not overturned the decision in the Agency's Approvable Letter of May 2007.

Labopharm plans to appeal the matter to the next supervisory level at the FDA in the coming weeks.

Labopharm initiated the Formal Dispute Resolution process in October of this year after receiving an Approvable Letter from the FDA for its once-daily formulation of tramadol in May.

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 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. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
2. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
3. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
4. Labopharm appeals FDAs decision on once-daily tramadol
5. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
6. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
7. Labopharm Reports Results for Third Quarter Fiscal 2007
8. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
9. DaVita Receives Civil Complaint
10. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
11. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... On Tuesday, April 26, 2016 members of the ... signature of Gov. Nathan Deal on SB 258, the “Rural Health Care Relief” Bill. ... a 70% tax credit to individuals and corporations which donate directly to a “rural ...
(Date:4/29/2016)... Fort Stewart, GA (PRWEB) , ... April 29, 2016 , ... ... on Monday, May 16, 2016, at its new location in the Exchange Furniture Mall ... including a raffle for a 50-inch Samsung Smart TV. Plus attendees will have the ...
(Date:4/29/2016)... ... April 29, 2016 , ... World Patent ... Gyrociser, an exercise invention which aids in proper muscle development. , "The Gym ... and Creative Director of World Patent Marketing. "Globalization has threatened the future growth ...
(Date:4/29/2016)... ... April 29, 2016 , ... Reltok Nasal Products proudly announces ... the head and neck/ear, nose and throat specialty, has added the KOTLER NASAL AIRWAY™ ... NASAL AIRWAY™ is a newly patented safety device secured by nasal surgeons onto ...
(Date:4/29/2016)... ... 2016 , ... CURE Media Group , the nation’s ... today announced that Lynne Malestic, RN, of Eisenhower Lucy Curci Cancer Center in ... Oncology Nursing , which honors nurses who have dedicated their careers to helping ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... , April 28, 2016   Click here ... Pharmacy, Inc. (NYSE: DPLO), the nation,s largest independent ... a definitive agreement to acquire Valley Campus Pharmacy, ... ("TNH"), a leading specialty pharmacy that provides individualized ... California . In 2015, TNH generated approximately ...
(Date:4/28/2016)... TOKYO , April 28, 2016 /PRNewswire/ ... Ahuja , George Phillips und ... wachsenden Unternehmens    ArisGlobal®, ein ... Life Sciences, gab heute bekannt, dass neue ... wachsenden Unternehmens gestoßen sind, die vielfältige Erfahrungen ...
(Date:4/28/2016)... Dr. Vivek Ahuja , ... Ste phen Schmidt Join the ... software solutions for life sciences, today announced key new leaders have ... insight to a growing business.  This will bolster the company,s safety ... joined ArisGlobal in the position of Vice President - Safety. ...
Breaking Medicine Technology: