This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryFDA's Anti-Infective Drug Products Advisory Committee unanimously recommends approval on July 28 of ciprofloxacin for post-exposure prophylaxis of clinical disease from inhaled Bacillus anthracis. The committee suggested that 60 days would be the appropriate duration of therapy. Bayer submitted supplemental NDAs for the anthrax prophylaxis indication on Feb. 29 at FDA's reques
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