- New PDUFA action date assigned -
LAVAL, QC, Aug. 25 /CNW/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today
announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's
response regarding its novel formulation of the antidepressant trazodone as
complete and designated it as a Class 2 resubmission. The FDA has assigned
Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February
Labopharm received a complete response letter from the FDA on July 17,
2009 indicating the Company's new drug application (NDA) for its novel
trazodone formulation could not be approved in its present form due to
deficiencies following the FDA's inspection of the manufacturing facility of
the active pharmaceutical ingredient (API) supplier, Angelini. The letter did
not raise any efficacy or safety issues. Angelini submitted an action plan
addressing the deficiencies to the FDA on July 24, 2009.
Labopharm continues to prepare for the commercialization of its novel
antidepressant and, pending FDA approval, intends to launch in the U.S.
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
now available in 17 countries around the world, including the U.S., Canada,
major European markets and Australia. The Company's second product, a novel
formulation of trazodone for the treatment of major depressive disorder, is
under regulatory review in the U.S. by the FDA. The Company also has a robust
pipeline of follow-on products in both pre-clinical and clinical development.
Labopharm's vision is to become an integrated, international, specialty
pharmaceutical company with the capability to internally develop and
commercialize its own products. For more information, please visit
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 in various
countries for the approval of the Company's products and the successful
commercialization of the products throughout the world 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.
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For further information:
For further information: At Labopharm: Mark D'Souza, Senior
Vice-President and Chief Financial Officer, Tel: (450) 686-0207; At The
Equicom Group: Jason Hogan, Media and Investor Relations, Tel: (416) 815-0700,
firstname.lastname@example.org; French: Joe Racanelli, Tel: (514) 844-7997,