Labopharm's New Drug Submission for once-daily tramadol accepted for review by Health Canada

By E. Janene Geiss

Philadelphia, Aug. 28 - Labopharm Inc. announced Monday that its New Drug Submission for its once-daily formulation of tramadol has been accepted for review by the Therapeutic Products Directorate of Health Canada.

The application is subject to a targeted 300-day review period, according to a company news release.

"It is our intention to commercialize our once-daily tramadol product in key markets globally and Canada represents a significant opportunity," James R. Howard-Tripp, president and chief executive officer, said in the release.

The application includes comprehensive data generated during the course of a global clinical development program and similar to that included in the company's New Drug Application to the Food and Drug Administration.

Tramadol is available in Canada only in an immediate-release formulation of the product that combines tramadol with acetaminophen.

Labopharm is a Laval, Quebec, specialty pharmaceutical company.

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