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Article: Axcan Initiates Phase III Clinical Trials on ITAX - Functional Dyspepsia Studies to be Carried Out in North America and Western Europe.
- Article from:
- PR Newswire
- Article date:
- May 13, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. 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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TSX SYMBOL (Toronto Stock Exchange): AXP NASDAQ SYMBOL (NASDAQ National Market): AXCA
Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has obtained the approval of the Therapeutic Products Directorate ("TPD") of Health Canada and Investigational New Drug ("IND") clearance from the Gastro-intestinal division of the Food and Drug Administration ("FDA"), required to initiate Phase III clinical trials to demonstrate safety and efficacy of ITAX (itopride hydrochloride) in the treatment of functional dyspepsia (also known as non- ulcer dyspepsia).
"We are very pleased to initiate our Phase III development program for ITAX in functional ...