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Home > Biosecurity Briefing > Archive > Countermeasure Development > 2008 > FDA Approves Antimicrobial for Pediatric Inhalational Anthrax Exposure (05-16-2008)
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FDA Approves Antimicrobial for Pediatric Inhalational Anthrax Exposure

By Brooke Courtney, May 16, 2008

According to a Drug Industry Daily news report, the U.S. Food and Drug Administration (FDA) approved Levaquin® (levofloxacin) for use in pediatric patients who have been exposed to Bacillus anthracis.1 This is the first and only pediatric indication for Levaquin. Levaquin, which is a quinolone antimicrobial agent manufactured by Ortho-McNeil, is approved for this indication in children six months of age or older in 250 mg, 500 mg, and 750 mg strength tablets, 5 mg/mL injection, and 25 mg/mL oral solution.1,2 While it has not been tested in humans for the post-exposure prevention of inhalational anthrax, Levaquin was already approved by the FDA to treat adults “to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.”2

References

  1. Astor A. Levaquin approved for pediatric anthrax exposure. Drug Industry Daily. May 8, 2008. http://www.fdanews.com/newsletter/article?articleId=106558&issueId=11568. Accessed May 15, 2008.
  2. Levaquin: Highlights of Prescribing Information. February 2008. http://www.levaquin.com/levaquin/shared/pi/levaquin.pdf#zoom=100. Accessed May 15, 2008.