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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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