FDA's Anti-Infective Drugs Advisory Committee

Executive Summary

July 18-19 agenda includes a review of Abbott's NDA (No. 50-662) for clarithromycin, an oral, second generation broad-spectrum macrolide antibiotic for lower respiratory tract, community-acquired upper respiratory tract, and skin and soft tissue infections. At a May analysts meeting, Abbott Chairman Duane Burnham noted that clarithromycin has a broader spectrum than erythromycin and higher potency. The advisory committee will also review the NDA (No. 50-670) for Pfizer's oral, once-daily, macrolide antibiotic Zithromax (azithromycin) for bacterial infections including sexually transmitted diseases, upper and lower respiratory tract infections, skin and skin structure infections and pediatric infections. Pfizer, which filed the NDA in April 1990, has claimed that clarithromycin "does not share the remarkable targeted delivery and pharmacokinetic properties of azithromycin." The NDAs will be discussed on the first day of the meeting, which begins at 8:30 a.m. in conference rooms D & E at FDA's Parklawn BUilding. The second day is set aside for closed committee deliberations on pending NDAs.