Vicuron’s second anidulafungin NDA
This article was originally published in Pharmaceutical Approvals Monthly
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)...