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Vicuron’s second anidulafungin NDA

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Vicuron submits an NDA Aug. 18 for use of its antifungal anidulafungin in invasive candidiasis/candidemia, putting a user fee date at June 18, 2006. The NDA includes a "Phase III trial demonstrating superiority of anidulafungin versus fluconazole [Pfizer's Diflucan and generics]," Vicuron says. Pfizer is acquiring Vicuron for $1.9 bil. (1Pharmaceutical Approvals Monthly July 2005, p. 26). An anidulafungin NDA for esophageal candidiasis has a Nov. 27 user fee deadline; invasive candidiasis was originally part of that submission, but Vicuron split the indications to speed approval (2Pharmaceutical Approvals Monthly October 2004, p. 14)...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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