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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:
11/11/2016
Trade Name:
Naftin
Generic Name or Proper Name (*):
naftifine hydrochloride
Indications Studied:
Tinea corporis in pediatric patients 2 years and older
Label Changes Summary:
*Expanded the indication down to pediatric patients 2 years and older; previously approved in pediatric patients 12 years and older. *Safety and effectiveness in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, pharmacokinetic parameters, and clinical trials. *Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Merz Pharmaceuticals
NNPS:
FALSE
Therapeutic Category:
Antifungal, topical
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