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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:  03/02/2018
 
Trade Name:  Otiprio Otic Suspension
 
Generic Name or Proper Name (*):  ciprofloxacin
 
Indications Studied:  Treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus
 
Label Changes Summary:  *Safety and effectiveness for the treatment of acute otitis externa was established in 67 pediatric patients (3 through 17 years of age) who participated in the Phase 3 trial; 57% of patients were 3 through 11 years of age and 43% of patients were 12 through 17 years of age. *Safety and effectiveness in infants below 6 months of age have not been established. *The adverse reactions in pediatric patients were similar to those observed in adults. *Information on clinical trial. *New indication.
 
PREA(P):  P
 
Sponsor:  Otonomy, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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