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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:  05/01/2009
 
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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Salvat
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic, topical
 
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