Medindia

X

Labopharm Receives FDA Response To Recent Appeal Of Approvable Letter For Once-Daily Tramadol

Friday, January 25, 2008 General News J E 4
Advertisement
LAVAL, QC, Jan. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS;NASDAQ: DDSS) today announced that it has received a written response from theU.S. Food and Drug Administration (FDA) regarding its most recent appeal ofthe decision in the Agency's Approvable Letter for its once-daily tramadolformulation through the Formal Dispute Resolution process. John K. Jenkins,M.D., Director for the Office of New Drugs, Center for Drug Evaluation andResearch, did not overturn the decision. However, Dr. Jenkins has suggestedadditional statistical analysis of existing data as a means to potentiallysatisfy the Agency's requirements. The statistical method proposed for theanalysis is different from that previously requested by the FDA since the May2007 Approvable Letter. Dr. Jenkins also recommended the Company meet with theAgency prior to any resubmission.

"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.
Advertisement


Advertisement

You May Also Like

Advertisement
View All

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions
s
Pharmacyclics Reports Second Quarter 2008 Financia...
S
Reckitt Benckiser Announces Completion of Cash Ten...