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FDA Approves Primary Biliary Cirrhosis Treatment MONTREAL, QC -- December 11, 1997 -- The United States Food and Drug Administration (FDA) has granted manufacturing and marketing clearance to Urso(R) (ursodiol 250 mg tablets) for the treatment of primary biliary cirrhosis (PBC). PBC is a chronic, progressive cholestatic liver disease of unknown origin. Some 50,000 people in the United States have the disease. At present, patients survive an average of 10 years after diagnosis. Liver transplant is the only current treatment modality for end-stage patients. Findings indicate that Urso is the only effective and safe drug for the treatment of PBC. It improves the survival rate of patients free of liver transplantation and improves liver biochemistry. The drug will be marketed in the United States by Axcan Schwarz LLC, a joint venture created in January 1997 by Axcan Pharma Inc. and Schwarz Pharma US. More information on: Axcan, Urso E-mail this page to a friend or colleague! To print, use this version