In Brief: FDA Anti-Infective Drugs Advisory Committee

Executive Summary

FDA Anti-Infective Drugs Advisory Committee: Will meet July 24 to discuss Mylan's Sulfamylon sulfadiazine cream 1% for treatment of patients with chronic wounds ("The Pink Sheet" May 13, T&G-6). The committee also will discuss Mylan's sulfamylon solution 5% (NDA 19-832) for control of bacterial colonization on excised burn wounds. On July 25-26, the committee will discuss antibiotic resistance issues, including development of FDA policy on agents for multidrug-resistant organisms and labeling issues. FDA is encouraging the submission of comments on development of drugs for multidrug-resistant infections. The meeting will begin at 8:30 a.m. each day at the Holiday Inn in Silver Spring, Md...