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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:
12/10/2015
Trade Name:
Otiprio
Generic Name or Proper Name (*):
ciprofloxacin otic suspension
Indications Studied:
Treatment of pediatric patients 6 months and older with bilateral otitis media with effusion undergoing tympanostomy tube placement
Label Changes Summary:
*Indicated in pediatric patients 6 months and older. *Safety and effectiveness was established in 530 pediatric patients with bilateral otitis media with middle ear effusion undergoing myringotomy with tympanostomy tube placement. The median age of patients enrolled in the clinical trials was 1.5 years. *The safety and effectiveness in infants below six months of age have not been established. *Information on administration, adverse reactions, and clinical trials. *New drug.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Otonomy, Inc.
NNPS:
FALSE
Therapeutic Category:
Antibiotic, topical
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