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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:
12/17/2014
Trade Name:
Xtoro
Generic Name or Proper Name (*):
finafloxacin
Indications Studied:
Treatment of acute otitis externa
Label Changes Summary:
*New approval *The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in two randomized multicenter, vehicle controlled clinical trials in total of 1234 patients aged 6 months to 85 years. *PK analyses were performed in 14 healthy adult volunteers and 36 patients ages 6 years and older with AOE. *The safety and efficacy of XTORO below one year of age have not been established
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Alcon
Pediatric Exclusivity Granted Date:
08/25/2014
Therapeutic Category:
Anti-inflammatory, topical
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