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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:
05/18/2010
Trade Name:
Zymaxid
Generic Name or Proper Name (*):
gatifloxacin
Indications Studied:
Bacterial conjunctivitis
Label Changes Summary:
Safety and effectiveness have been demonstrated in clinical trials for the treatment of bacterial conjunctivitis in pediatric patients 1 year and older The safety and effectiveness in infants < 1year have not been established Information on adverse reactions and clinical trials New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Allergan
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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