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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:
12/11/2017
Trade Name:
Xepi
Generic Name or Proper Name (*):
ozenoxacin
Indications Studied:
Impetigo in adults, adolescents and children 2 months and older
Label Changes Summary:
*Safety and effectiveness in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. *Use in pediatric patients 2 months to 17 years of age is supported by evidence from adequate and well-controlled studies in which 251 pediatric patients received at least one dose of Xepi. *Safety and effectiveness in pediatric patients younger than 2 months of age have not been established. *Information on adverse reactions and clinical trials.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Ferrer Internacional S.A.
NNPS:
FALSE
Therapeutic Category:
Antibiotic, topical
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