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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:  09/25/2017
 
Trade Name:  Genvoya
 
Generic Name or Proper Name (*):  elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
 
Indications Studied:  elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
 
Label Changes Summary:  *Approved for use in pediatric patients weighing at least 25 kg; previously approved in 12 to less than 18 years and weighing at least 35 kg. *Use in pediatric patients weighing at least 25 kg is supported by studies in adults and by an open-label trial in virologically-suppressed pediatric patients 6 to less than 12 years and weighing at least 25 kg, in which subjects were switched from their antiretroviral regimen to Genvoya. *Safety and effectiveness in pediatric patients less than 25 kg have not been established. *Safety profile in pediatric patients who received treatment was similar to that in adults. *Information on dosing, adverse reactions, and clinical trial.*Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antviral
 
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