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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:
12/21/2012
Trade Name:
Altabax Ointment
Generic Name or Proper Name (*):
retapamulin
Indications Studied:
Treatment of impetigo
Label Changes Summary:
Use of retapamulin is not indicated in pediatric patients < 9 monthsIn an open-label clinical study of topical treatment in pediatric patients 2 to 24 months, systemic exposure of retapamulin was higher compared with patients 2 to 17 years. A higher proportion of pediatric patients 2 to 9 months of age had measurable concentrations of retapamulin compared with patients 9 to 24 months of age. The highest levels were seen in patients 2 to 6 months of agePostmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Stiefel Laboratories
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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