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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:  12/30/2014
 
Trade Name:  Natroba
 
Generic Name or Proper Name (*):  spinosad
 
Indications Studied:  Head lice infestation
 
Label Changes Summary:  *Extended the use of Natroba to pateints aged 6 months and older. *A 23-day open-label study assessed the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric patients in 26 pediatric patients aged between 6 months to 4 years *Plasma spinosad and benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification for all subjects tested *Safety in pediatric patients below the age of 6 months has not been established
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ParaPRO
 
Therapeutic Category:  Pediculocide, topical
 
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