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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:
12/30/2014
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
PREA(P):
P
Sponsor:
ParaPRO
Therapeutic Category:
Pediculocide, topical
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