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Ciba-Geigy's Actigall

Executive Summary

For the treatment of primary biliary cirrhosis will be the topic of a July 28 FDA Gastrointestinal Drugs Advisory Committee meeting. The review of Actigall (ursodiol) will be based on data submitted by Ciba in supplementary NDA 19-594/015. Actigall, marketed by Ciba's Summit Pharmaceuticals, is approved in the U.S. in a tablet formulation for the dissolution of radioluscent, non- calcified gallstones less than 20 mm in greatest diameter. The meeting will be at Parklawn, conference rooms G, H & I beginning at 9 a.m
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PS024668

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