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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Pfizer’s anidulafungin received a second “approvable” letter Nov. 25 for treatment of esophageal candidiasis, FDA said.
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