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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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