Pfizer receives FDA approvable letter for dalbavancin

NEW YORK Pfizer announced this week that the Food and Drug Administration has issued them an approvable letter for the antibiotic dalbavancin.

The FDA has requested additional information regarding the drug, which is indicated for skin infections. The letter referred to manufacturing issues at a third-party manufacturer, not specifically related to the drug. The manufacturer is working with the FDA to resolve these issues, Pfizer said, also noting that the FDA had a separate question about storage time.

Pfizer acquired dalbavancin as part of its September 2005 purchase of Vicuron Pharmaceuticals, which also produces anti-fungal anidulafungin.