Table of Contents
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Ciprofloxacin Anthrax post-exposure prophylaxis
Agenda
Introduction
Proposed Labeling
Approved CIPROŽ Formulations
Approved CIPROŽ Oral and I.V. Indications
Events Leading to Anthrax Submission
Events Leading to Anthrax Submission
Events Leading to Anthrax Submission
Events Leading to Anthrax Submission
Events Leading to Anthrax Submission
Concurrent Events
Final Events Leading to Anthrax Submission
Rationale for the Use of Ciprofloxacin
Pharmacokinetics/Pharmacodynamics
Pharmacokinetics/Pharmacodynamics
Pharmacokinetics/Pharmacodynamics
Tissue Penetration
CIPROŽ Clinical Database
Review of US Lower Respiratory Tract Infection Clinical Database
Clinical Success Rates in the LRTI Pooled Studies
Review of Overall Clinical Trials Safety Database
Review of Global Clinical Trials Safety Database
CIPROŽ Pediatric Experience
Review of Controlled Pediatric Clinical Trial Safety Database
Ciprofloxacin Global Clinical Trials Pediatric Safety Database
CIPROŽ Pediatric Experience
CIPROŽ Pediatric Experience
CIPROŽ - Review of Global Post-Marketing Safety Database
Ciprofloxacin Spontaneous ADE Reports1 Ten Most Frequently Reported Events (All Formulations)
Most Frequently Reported Ciprofloxacin Spontaneous ADE Reports1 By Age (When Known) (All Formulations)
Ciprofloxacin Spontaneous ADE Reports1 Ten Most Frequently Reported Serious Events (All Formulations)
Summary
Conclusions
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