US Food and Drug Administration approval of ciprofloxacin hydrochloride for management of postexposure inhalational anthrax.
In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for use in treating an infection due to a biological agent used intentionally. The terrorist attacks of 2001 involving anthrax underscore the imperative that safe and effective drugs to manage such infections be readily available in the United States. The approval of ciprofloxacin hydrochloride, which was made on the basis of a surrogate human marker of efficacy, made extensive use of data from an animal model of disease. This represents a new direction in the development of efficacy data in support of drug approval and facilitates the availability of those drugs for which there is an urgent need. This article presents the scientific data and regulatory mechanism that supported the approval of ciprofloxacin hydrochloride for management of postexposure of inhalational anthrax.
US Food and Drug Administration, Rockville, MD, USA. am282@gunet.georgetown.edu
Andrea
A
Meyerhoff
Renata
R
Albrecht
Joette M
JM
Meyer
Peter
P
Dionne
Karen
K
Higgins
Dianne
D
Murphy
D000328:Adult; D000818:Animals; D000881:Anthrax / Q000188:drug therapy*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001408:Bacillus anthracis; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004195:Disease Models, Animal; D004334:Drug Administration Schedule; D017277:Drug Approval; D006801:Humans; D019570:Inhalation Exposure; D008253:Macaca mulatta; D013171:Spores, Bacterial; D014481:United States; D014486:United States Food and Drug Administration
D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin