Anti-Infective Drugs Advisory Committee

Supplemental New Drug Applications(NDA)

19-537/S038, 19-847/S024, 19-857/S027, 19-858/S021, 20-780/S008

for CiproŽ (ciprofloxacin), Bayer Corporation, Pharmaceutical Division

July 28, 2000

Briefing Information

FDA Briefing Information pdf doc

Pile, James C. MD, et al, "Anthrax as a potential biological warfare agent," Arch Intern Med 158: 429-34; Mar 9, 98.*

Abramova et al, "Pathology of inhalational anthrax in 42 cases fro the Sverdlovsk outbreak of 1979," Proc Natl Acad Sci USA 90: 2291-94 March 1991.*

Meselson, M. et al, "The Sverdlovsk anthrax outbreak of 1979," Science 266: 1202-08; Nov 18, 94.*

Reprint fo Cipro Tablet/Suspension Label

Reprint of Cirpo IV Label

Friedlander et al, "Postexposure prophylaxis against experimental inhalational anthrax," J Infect Dis 167: 1239-42, 1993.*

Kelly et al, "Serum Concentrations of Penicillin, Doxycycline, and Ciprofloxacin during Prolonged Therapy in Rhesus Monkeys," J Infect Dis 166: 1184-7, 1992.*

Henderson et al, "Observations on the prophylaxis of experimental pulmonary anthrax in the monkey," J hyg 54: 28-36, 1956.*

Ross, "The Pathogenesis of Anthrax Following the Administration of Spores by the Respiratory Route," J Path Bact 73: 495-494, 1957.*

Segev et al, "Safety of long term therapy with ciprofloxacin," Clin Infect Dis 28: 299-308, 1999.*

Hampel et al, "Ciprofloxacin in pediatrics," Pediatr Infect Dis J, 16: 127-9, 1997.*

*Copyrighted material.  Material may be viewed at:  Dockets Management Branch, Food and Drug Adminstration, 5630 Fishers Lane, Room 1061, Rockville, MD 20857