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Salix rifaximin "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Final approval of Salix' traveler's diarrhea antibiotic rifaximin awaits results from a third study that began in early 2002, FDA says in Oct. 25 "approvable" letter. Salix hopes to have enrollment in the study wrapped up by the end of the year. The company is evaluating new brand names for the product following FDA's rejection of the proposed name Lumenax
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