Pfizer dalbavancin "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer's lipoglycopeptide antibiotic dalbavancin is "approvable" Sept. 21 for treatment of chronic skin and soft tissue infections. The agent is receiving a priority review but FDA extended its action date by 90 days in May following a major amendment relating to chemistry, manufacturing & controls (1Pharmaceutical Approvals Monthly May 2005, In Brief). Pfizer's acquisition of innovator Vicuron closed Sept. 11...