Anti-Infective Drugs Advisory Committee

January 30, 2001

NDA 50-755 Augmentin (amoxicillin/clavulantate potassium)

Slides

Acute Otitis Medial Trials: Evolution of Guidance, Janice Soreth, MD, FDA   ppt   htm

Otitis Medial Epidemiology and Drug-Resistant Streptoccus pneumoniae, G Scott Giebink, MD, University of Minnesota School of Medicine   ppt   htm

Augmentin ES for acute otitis media, Mamodikoe Makhene, MD, FDA   ppt   htm

Augmentin ES Suspension Summary of PK/PD Data, He Sun, PhD, Frank Pelsor, PharmD, FDA   ppt   htm

Augmentin ES Clinical Microbiology Review, Sousan S Altaie, PhD, FDA   ppt   htm

Anti-Infective Advisory Committee, Dianne Murphy, MD, CDER   ppt   html

SmithKline Beecham

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Augmentin ES

Importance of Time Above MIC for In-Vivo Activity of Augmentin and Other Beta-Lactams in Acute Otits Media, William A Craig, MD, University of Wisconsin-Madison

Measuring the Efficacy of Antibiotic Therapy in Acute Otitis Media, Colin D Marchant, MD, Boston University School of Medicine & Tufts University School of Medicine

Augmentin ES Bacteriological and Clinical Efficacy in AOM, Brian Wynne, MD