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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:  03/01/2016
 
Trade Name:  Odefsey
 
Generic Name or Proper Name (*):  emtricitabine, rilpivirine, and tenofovir alafenamide
 
Indications Studied:  Treatment of HIV-1 infection in patients 12 years of age and older
 
Label Changes Summary:  * Safety and efficacy of Odefsey was established in pediatric patients 12 years and older weighing 35 kg or more. * Use of Odefsey in this age group is supported by adequate and well-controlled studies in adults with HIV-1 infection, and by 2 pediatric studies in 59 pediatric patients 12 to < 18 years. * Safety and efficacy have not been established in pediatric patients less than 12 years of age or weighing less than 35 kg. * Safety was similar to that observed in adults. * Information on clinical trials, adverse reactions. * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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