Vicuron dalbavancin 90-day extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Vicuron continues to plan a first-quarter 2006 launch of its lipoglycopeptide antibiotic dalbavancin despite FDA's 90-day extension of its original priority review user fee date of June 21. FDA reset the action date after deeming the company's responses to chemistry, manufacturing and controls questions to be a major amendment. The firm is seeking an indication for treatment of chronic skin and soft tissue infections. Vicuron has another antibiotic NME pending at FDA: anidulafungin has been "approvable" since May 2004 for esophageal candidiasis; the firm plans to respond in the second quarter...