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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:  05/28/2009
 
Trade Name:  Besivance
 
Generic Name or Proper Name (*):  besifloxacin ophthalmic suspension
 
Indications Studied:  Treatment of bacterial conjunctivitis
 
Label Changes Summary:  Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials Safety and effectiveness in infants < 1 year of age have not been established There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints Information on AE profile and clinical study New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bausch and Lomb
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic, topical
 
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