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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:
10/10/2014
Trade Name:
Naftin
Generic Name or Proper Name (*):
naftifine hydrochloride
Indications Studied:
Interdigital tinea pedis
Label Changes Summary:
Use in 12 – 18 years is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial in 22 adolescents 12 years and older exposed to Naftin Gel at a dose of approximately 4 g/day Safety and effectiveness in pediatric patients less than12 years have not been established Adverse reactions were similar to those observed in adults Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Merz Pharmaceuticals
NNPS:
FALSE'
Therapeutic Category:
Antifungal, topical
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