Vicuron Submits NDA For Additional Anidulafungin Indication
This article was originally published in The Pink Sheet Daily
Executive Summary
The invasive candidiasis/candidemia indication was spun off from a pending NDA for esophageal candidiasis.
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Vicuron's NDA for a second indication for its antifungal agent anidulafungin has an estimated user fee date of June 18, 2006. The company submitted the NDA for invasive candidiasis/candidemia on Aug. 18. Also pending at FDA is an amended anidulafungin NDA for the treatment of esophageal candidiasis. The company originally submitted one NDA for both indications. That application received an "approvable" letter in May 2004. The firm later decided to divide the submission into separate indications (1 (Also see "Vicuron Will Resubmit Anidulafungin For Invasive Candidiasis Under Separate NDA" - Pink Sheet, 21 Sep, 2004.)). The esophageal candidiasis indication has a Nov. 27 user fee date, the firm said. Vicuron also has an application pending at FDA for its lipoglycopeptide antibiotic dalbavancin; the user fee date is Sept. 21 (2 (Also see "Vicuron's Dalbavancin User Fee Date Extended To Sept. 21" - Pink Sheet, 11 May, 2005.)). Pfizer's $1.9 bil. acquisition of Vicuron is expected to close in the third quarter. - Christopher Hollis |