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JULY 2, 2018

FDA Approves Expanded Indication for Truvada for PrEP for Adolescents

By SPC News Staff

The FDA granted a new indication for emtricitabine-tenofovir disoproxil fumarate (FTC/TDF; Truvada, Gilead Sciences)—in combination with safer sex practices—to reduce the risk for sexually acquired HIV-1 in at-risk adolescents. 

The safety and efficacy profile of FTC/TDF for pre-exposure prophylaxis (PrEP) in adults is well established, and FTC/TDF for PrEP was first approved for use in adults in 2012.

The addition of the adolescent indication is based on a study