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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:
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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