Vicuron Will Resubmit Anidulafungin For Invasive Candidiasis Under Separate NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Current NDA will focus on esophageal candidiasis indication; Vicuron plans to submit an amendment in second quarter 2005 to address FDA’s concerns about the “approvable” antifungal. Invasive candidiasis NDA filing is slated for third quarter 2005.
You may also be interested in...
Pfizer “Approvable” Streak Continues With Second letter For Anidulafungin
The antifungal agent’s second approvable letter is for an esophageal candidiasis indication.
Pfizer “Approvable” Streak Continues With Second letter For Anidulafungin
The antifungal agent’s second approvable letter is for an esophageal candidiasis indication.
Vicuron Submits NDA For Additional Anidulafungin Indication
The invasive candidiasis/candidemia indication was spun off from a pending NDA for esophageal candidiasis.