Approved December 1997
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.
The Urso drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.