ARTICLE | Company News

Pfizer withdraws dalbavancin applications

September 10, 2008 1:16 AM UTC

Pfizer (NYSE:PFE) withdrew an NDA in the U.S. and an MAA in Europe for dalbavancin to treat complicated skin and skin structure infections (cSSSIs). Dalbavancin received FDA approvable letters in 2005, 2006 and 2007. In the letter Pfizer received last December, the agency requested additional data.

Pfizer said it would run an additional, global Phase III trial of dalbavancin to focus on patients with severe cSSSIs. The company said the 18-month trial will be a non-inferiority study, per draft guidance published by FDA last year on studies designed to show non-inferiority of antibacterial drug candidates (See BioCentury, Oct. 29, 2007). ...