CIBA-GEIGY's ACTIGALL FOR BILIARY CIRRHOSIS IS NOT READY FOR APPROVAL RECOMMENDATION: FDA WORKING WITH SPONSOR ON STUDY METHODOLOGY, CONSISTENCY, ANALYSIS
Executive Summary
FDA is discussing Ciba-Geigy's supplemental NDA for Actigall for primary biliary cirrhosis with the company to attempt to resolve questions about methodology, consistency and analysis in two clinical studies.