emtricitabine and tenofovir disoproxil fumarate

FDA Drug Profile — Truvada

Drug Details

Generic Name
emtricitabine and tenofovir disoproxil fumarate
Brand Names
Truvada
Application Number
NDA021752
Sponsor
Patheon Inc.
NDC Codes
15
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. ( 1 )