Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

FDA Drug Profile — SYMFI, Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

Drug Details

Generic Name
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Brand Names
SYMFI, Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Application Number
NDA022142
Sponsor
Viatris Specialty LLC
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
EFAVIRENZ, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE SYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. SYMFI is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. ( 1 )