Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Gastroenterology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Axcan
Approval Status: Approved December 1997
Treatment Area: primary biliary cirrhosis
Urso has been approved for the treatment of primary biliary
cirrhosis.
The approval rested primarily on the results of two Phase III
trials conducted in approximately 300 patients. A two-year
180-patient study performed by the Mayo Clinic dosed patients at
13-15 mg/kg per day with Urso tablets 250 mg four times daily.
Among patients receiving Urso, 23% were considered treatment
failures compared to 47% in the placebo group.
