Efavirenz

FDA Drug Profile — Efavirenz

Drug Details

Generic Name
Efavirenz
Brand Names
Efavirenz
Application Number
ANDA077673
Sponsor
Siegfried St. Vulbas SAS
NDC Codes
21
Dosage Forms
POWDER, CAPSULE, TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
EFAVIRENZ

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 )