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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Janssen
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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