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Article: Labopharm Falls 50 Percent On Second FDA Approvable Letter.
- Article from:
- BIOWORLD Today
- Article date:
- June 4, 2007
- Author:
CopyrightCOPYRIGHT 2007 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Jim Shrine, Staff Writer
Labopharm Inc. lost more than half its value Friday after suffering a second setback in its plan to get FDA approval for a once-daily formulation of the analgesic tramadol.
The FDA sent Labopharm a second approvable letter on its new drug application, this one saying the Laval, Quebec-based company failed to demonstrate efficacy due to faulty statistical methodology. Labopharm shares (NASDAQ:DDSS) fell 51.4 percent Friday, or $3.24, to close at $3.07.
The first approvable letter from the FDA came in late September. Labopharm in December said it submitted a complete response that included additional analysis of ...