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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:  07/16/2018
 
Trade Name:  Intelence
 
Generic Name or Proper Name (*):  etravirine
 
Indications Studied:  Treatment of HIV-1 infection in patients 2 years to less than 6 years of age weighing at least 10 kg
 
Label Changes Summary:  *Expanded the patient population to include pediatric patients 2 years to less than 6 years weighing at least 10 kg; previously approved in pediatric patients 6 years and older. *Use in pediatric patients 2 years to less than 6 years of age is supported by evidence from adequate and well-controlled studies in adults with additional data from a study in 20 pediatric patients 2 years to less than 6 years. *Treatment is not recommended in pediatric patients less than 2 years. *The pharmacokinetics and dose of etravirine in pediatric patients less than 2 years have not been established. *Safety was similar to that observed in adults. *Information on adverse drug reactions, pediatric trial. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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