LAVAL, QC, Jan. 16 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that its response to matters raised by the U.S. Food and Drug Administration (FDA) in the approvable letter for Labopharm's once-daily formulation of tramadol has been accepted for review by the FDA as complete. The action date assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is June 19, 2007.
Labopharm received the approvable letter for its once-daily formulation of tramadol on September 28, 2006 following submission of its New Drug Application on November 28, 2005. Following discussions with the FDA, Labopharm submitted its response to the matters raised in the approvable letter for once-daily tramadol on December 19, 2006.
About Labopharm Inc.
Labopharm Inc. is an international specialty pharmaceutical company focused on the development of drugs incorporating the Company's proprietary advanced controlled-release technologies. The Company's lead product, a once-daily formulation of the analgesic tramadol, has been approved and launched in Europe and is currently under review for approval by the U.S. Food and Drug Administration. For more information, please visit www.labopharm.com.
This press release contains forward-looking statements that involve a number of risks and uncertainties relating to the Company's once-daily tramadol product in the United States that could cause actual results to differ materially from those indicated in the forward-looking statements. These statements reflect the Company's current expectations regarding future events. Specifically the risks and uncertainties the Company faces include but are not limited to: the Company's ability to resolve the issues identified by the FDA to the FDA's satisfaction in a timely manner; the uncertainties related to the regulatory process, including regulatory approval, and the commercialization of the drug thereafter. There can be no assurance that the Company will be able to resolve the issues identified by the FDA using existing data, or at all. If the Company is unable to resolve the issues identified by the FDA using existing data, it would need to generate additional data in order to obtain FDA approval. The Company's once-daily formulation of tramadol may not be legally marketed in the United States prior to approval by the FDA. 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.
CONTACT: At Labopharm: Mark D'Souza, Chief Financial Officer, Tel: (450)680-2444; At The Equicom Group: Jason Hogan, Media and Investor Relations,Tel: (416) 815-0700, firstname.lastname@example.org; French: Eric Bouchard, Tel:(514) 208-5939, email@example.com