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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  04/27/2012
 
Trade Name:  Levaquin
 
Generic Name or Proper Name (*):  levofloxacin
 
Indications Studied:  Treatment and prophylaxis of plague due to Yersinia pestis
 
Label Changes Summary:  Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals Safety and effectiveness in pediatric patients < 6 months have not been established Information on animal study New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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