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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Otonomy, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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