Truvada

Product manufactured by Gilead Sciences, Inc

Application Nr Approved Date Route Status External Links
NDA021752 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Hiv-1 Treatment ( 1.1 ) Truvada Is A Two-Drug Combination Of Emtricitabine (Ftc) And Tenofovir Disoproxil Fumarate (Tdf), Both Hiv-1 Nucleoside Analog Reverse Transcriptase Inhibitors, And Is Indicated: In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 17 Kg. Hiv-1 Prep ( 1.2 ): Truvada Is Indicated In At-Risk Adults And Adolescents Weighing At Least 35 Kg For Pre-Exposure Prophylaxis (Prep) To Reduce The Risk Of Sexually Acquired Hiv-1 Infection. Individuals Must Have A Negative Hiv-1 Test Immediately Prior To Initiating Truvada For Hiv-1 Prep. 1.1 Treatment Of Hiv-1 Infection Truvada Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 17 Kg [See Clinical Studies (14) ] . 1.2 Hiv-1 Pre-Exposure Prophylaxis (Prep) Truvada Is Indicated In At-Risk Adults And Adolescents Weighing At Least 35 Kg For Pre-Exposure Prophylaxis (Prep) To Reduce The Risk Of Sexually Acquired Hiv-1 Infection. Individuals Must Have A Negative Hiv-1 Test Immediately Prior To Initiating Truvada For Hiv-1 Prep [See Dosage And Administration (2.2) , Warnings And Precautions (5.2) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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