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U.S. Department of Health and Human Services

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 months* In 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 age*Postmarketing study
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Stiefel Laboratories
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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