s marketing partner, Paladin Labs Inc., launched
once-daily tramadol in Canada under the brand name Tridural(TM). The
Company also completed licensing and distribution agreements for once-daily
tramadol for South Korea with WhanIn Pharmaceutical Co., Ltd., for Greece
with Lavipharm S.A. and for Israel with Dexcel Pharma Technologies Ltd.
Labopharm expects its product to be launched in the South Korean and Greek
markets in 2008. Labopharm's formulation is currently under regulatory
review in Israel and the Company expects a response from the Israeli
regulatory authority by mid-2008.
To date, Labopharm has secured marketing partners for its once-daily
tramadol in more than 50 countries worldwide and regulatory approval in 25
countries. The Company's partners will continue to launch its product in
additional markets, globally, throughout 2008.
In the U.S., Labopharm continues to vigorously pursue regulatory
approval of its once-daily tramadol, appealing the U.S. Food and Drug
Administration's (FDA) decision in its Approvable Letter through initiation
of the Agency's Formal Dispute Resolution process. The Company believes
that it has met the statutory standards for approval of its formulation and
that appealing the FDA's decision through this process represents its best
opportunity to expeditiously resolve this matter.
(1) Labopharm's target market consists of the market for
immediate-release, twice-daily, once-daily and drop formulations of
(2) Includes France, Germany, the United Kingdom, Spain and Italy.
Once-Daily Trazodone Development Program
Labopharm has completed patient enrolment in its North American Phase
III clinical trial for its once-daily formulation of the antidepressant
trazodone, ahead of schedule. More than 400 patients are enrolled in the
"Our once-daily formulation represents the opportunity to address
significant unmet needs in t
Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Related medicine news :1
|SOURCE Labopharm Inc.|
Copyright©2007 PR Newswire.
All rights reserved
. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy2
. Labopharm provides update on U.S. regulatory process for once-daily Tramadol3
. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug4
. Labopharm appeals FDAs decision on once-daily tramadol5
. 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 Conference7
. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites8
. Haemacure Reports Third Quarter 2007 Results9
. First-Ever List of the 5,000 Fastest-Growing Businesses Reports Total Revenue of $194.5 Billion10
. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best11
. MDS Reports Third Quarter 2007 Results