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Article: Axcan Submits URSO 500 mg Tablets for Approval in the United States for the Treatment of Primary Biliary Cirrhosis.
- Article from:
- PR Newswire
- Article date:
- September 24, 2003
CopyrightCOPYRIGHT 2003 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") announced today that it has submitted to the U.S. Food and Drug Administration a supplemental New Drug Application for URSO in a 500 mg tablet dosage form ("URSO DS") for the treatment of Primary Biliary Cirrhosis ("PBC"). If approved, this new dosage form will complement the 250 mg URSO tablets Axcan currently markets in the U.S. for the treatment of PBC. Axcan launched URSO DS in Canada earlier this year for the treatment of cholestatic liver diseases.
"We are very pleased with the submission of this new stronger dosage form for ursodiol. If approved, we expect URSO DS to accelerate our penetration of the US ursodiol ...