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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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