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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:  04/12/2007
 
Trade Name:  Altabax Ointment 1%
 
Generic Name or Proper Name (*):  retapamulin
 
Indications Studied:  Treatment of impetigo in patients 9 months of age and older
 
Label Changes Summary:  * Safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age * Studies waived in children 0-2 months of age and deferred in children 2-9 months of age * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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