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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:  07/08/2011
 
Trade Name:  Truvada
 
Generic Name or Proper Name (*):  emtricitabine/tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV-1 infection in adolescents
 
Label Changes Summary:  * Expanded indication from adults to pediatric patients 12 years and older. * Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Truvada should only be administered to pediatric patients 12 years and older with body weight greater than or equal to 35 kg. * Information on dosing, adverse reactions, PK and clinical trial. * Postmarketing study
 
PREA(P):  P
 
Sponsor:  Gilead
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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