Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B) and PREA(P):
B,P
Sponsor:
Gilead
Pediatric Exclusivity Granted Date:
11/15/2018
NNPS:
FALSE
Therapeutic Category:
Antiviral
-
-