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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:  01/18/2011
 
Trade Name:  Natroba
 
Generic Name or Proper Name (*):  spinosad
 
Indications Studied:  Treatment of head lice infestation in patients 4 years of age and older
 
Label Changes Summary:  * Safety and effectiveness have been established in pediatric patients 4 years of age and older * Safety in pediatric patients < 4 years has not been established. * Not recommended in pediatric patients< 6 months because of the potential for increased systemic absorption* Natroba contains benzyl alcohol which has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity* Information on clinical trials, adverse reactions* New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ParaPRO
 
NNPS:  FALSE
 
Therapeutic Category:  Pediculocide, topical
 
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