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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:  12/11/2018
 
Trade Name:  Viread
 
Generic Name or Proper Name (*):  tenofovir disoproxil fumarate
 
Indications Studied:  Chronic hepatitis B (CHB) in pediatric patients 2 years and older weighing at least 10 kg
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials in which Viread was administered to HBV-infected treatment-experienced patients. *Safety and effectiveness in chronic HBV-infected pediatric patients younger than 2 years and weighing less than 10 kg have not been established. *The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in chronic HBV-infected pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown. *Information on dosing, adverse reactions, and clinical trials. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Gilead
 
Pediatric Exclusivity Granted Date:  11/15/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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