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Vicuron Anidulafungin User Fee Extended; Dalbavancin NDA Coming 2H 2004

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s request for additional bioavailability data on Vicuron’s anidulafungin has extended the user fee goal date to May 25.

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Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals

Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities

Year-End 2004 Submissions Slow; FDA Returns To Boom In Approvals

Year-end submissions are down, but end-of-year approvals are up at 15 versus six in 2003. December 2004 saw 14 filings compared to 17 a year ago. Submission slow-down reflects diminishing late-stage pipelines across industry; only five of the end-of-year filings were for new molecular entities

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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