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Vicuron To File Anidulafungin For Invasive Candidiasis Under Separate NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Vicuron’s revised regulatory strategy for anidulafungin involves filing a separate NDA for treatment of invasive candidiasis/candidemia and addressing other concerns through labeling discussions.

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Anidulafungin filing

Vicuron (formerly Versicor) submits NDA for anidulafungin for the treatment of esophageal candidiasis, the firm announces April 28. The NDA also contains data on invasive candidemia/candidiasis and aspergillosis (1Pharmaceutical Approvals Monthly April 1, In Brief). The antifungal is the third filing in the echinocandin class, following Merck's approved Cancidas (caspofungin) and Fujisawa's "approvable" micafungi

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