Axcan Urso recommended for primary biliary cirrhosis indication by FDA advisory committee.
Executive Summary
AXCAN PHARMA URSO FOR PRIMARY BILIARY CIRRHOSIS APPROVAL RECOMMENDED by FDA's Gastrointestinal Drugs Advisory Committee at its Nov. 5 meeting. The committee voted unanimously that the ursodeoxycholic acid product is safe and effective for the treatment of primary biliary cirrhosis. Further studies should not be required for approval, the committee decided.