LAVAL, QC, Nov. 21 /CNW/ - 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 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.
For further information:
For further information: At Labopharm: Mark D'Souza, Chief Financial
Officer, Tel: (450) 686-0207; At The Equicom Group: Jason Hogan, Media and
Investor Relations, Tel: (416) 815-0700, email@example.com; French: Eric
Bouchard, Tel: (514) 844-7997, firstname.lastname@example.org