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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:
05/01/2009
Trade Name:
Cetraxal
Generic Name or Proper Name (*):
ciprofloxacin otic solution
Indications Studied:
Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus
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 have not been established There is no evidence that the otic administration of quinolones has any effect on weight bearing joints Information on AE profile and clinical study New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Salvat
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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