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Bayer Cipro

Executive Summary

Ciprofloxacin sNDA for post-exposure prophylaxis of clinical disease from inhaled Bacillus anthracis unanimously recommended by FDA's Anti-Infective Drug Products Advisory Committee July 28. The panel also unanimously agreed that a 60-day time period is appropriate duration of therapy. Data from a study performed in a non-human primate (macaque) model, supported by in vitro data on the effect of ciprofloxacin on B. anthracis, formed the basis of committee deliberations. Cipro was initially approved in 1987
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PS036402

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