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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:
05/28/2009
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
PREA(P):
P
Sponsor:
Bausch and Lomb
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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