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Article: Axcan Pharma Reports Positive Pre-Ind Meeting for ITAX - Functional Dyspepsia Phase III Studies to be Initiated Upon Ind Filing; TSX SYMBOL (Toronto Stock Exchange): AXP NASDAQ SYMBOL (NASDAQ National Market): AXCA.
- Article from:
- PR Newswire
- Article date:
- January 22, 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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Axcan Pharma Inc. ("Axcan" or the "Company") today announced the outcome of the meeting it held with the U.S. Food and Drug Administration ("FDA") on January 20, 2004, regarding ITAX (itopride hydrochloride). This meeting was held in preparation for the filing of an Investigational New Drug ("IND") for ITAX in the treatment of functional dyspepsia (also known as non-ulcer dyspepsia). During this meeting with the FDA's division of Gastrointestinal and Coagulation Drug Products, the FDA endorsed Axcan's proposal to conduct two Phase III pivotal double-blind, placebo controlled clinical studies to demonstrate the safety and efficacy of ITAX in the treatment of functional ...