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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:  03/24/2010
Trade Name:  Viread
Generic Name or Proper Name (*):  tenofovir disoproxil fumarate
Indications Studied:  Treatment of HIV infection in combination with other antiretroviral agents
Label Changes Summary:  * Expanded indication from adults to pediatric patients 12- <18 years * Safety and effectiveness in patients < 12 years have not been established * In a clinical study of HIV-1 infected adolescents bone effects were similar to adults * The adverse reactions in trial in adolescents were consistent with those observed in clinical trials in adults * Information on dosing in adolescents weighing e35 kg, adverse reactions, and PK parameters
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Gilead
Therapeutic Category:  Antiviral