Labopharm Receives FDA Response To Recent Appeal Of Approvable Letter For Once-Daily Tramadol
"We are encouraged by the FDA's recent communication and are currentlyevaluating the proposal outlined in the letter," said James R. Howard-Tripp,President and Chief Executive Officer, Labopharm Inc. "We look forward topotentially resolving the outstanding issues."
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existingsmall molecule drugs using its proprietary controlled-release technologies.The Company's lead product, a unique once-daily formulation of tramadol, isbeing commercially launched in key markets globally. The Company also has arobust pipeline of follow-on products in both pre-clinical and clinicaldevelopment. Labopharm's vision is to become a fully integrated,international, specialty pharmaceutical company with the capability tointernally develop and commercialize its own products. For more information,please visit www.labopharm.com.
This press release contains forward-looking statements, which reflect theCompany's current expectations regarding future events. The forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including the uncertainties related to the regulatory process for drugapproval and the commercialization of the Company's products, if they areapproved. Investors should consult the Company's ongoing quarterly filings andannual reports for additional information on risks and uncertainties relatingto these forward-looking statements. The reader is cautioned not to rely onthese forward-looking statements. The Company disclaims any obligation toupdate these forward-looking statements.
SOURCE Labopharm Inc.
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