Medication Monitor



Generic Name (Trade Name—Company)
Notes
March 29, 2018

Efavirenz/lamivudine/tenofovir disoproxil fumarate 600 mg/300 mg/300 mg

(Symfi—Mylan)
Triple-combination, once-daily HIV treatment approved in the U.S.

Mylan announced FDA approval of efavirenz, lamivudine, and tenofovir disoproxil fumarate 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), 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.

The combination is the most widely taken antiretroviral (ARV) regimen outside of the United States, with more than 7 million users worldwide in 2016.  

The introduction of the new combo comes after FDA's recent approval of two Mylan ARVs: lamivudine and tenofovir disoproxil fumarate 300 mg/300 mg tablets (Cimduo), a once-daily combination of two nucleo(t)side reverse transcriptase inhibitors, which is indicated in combination with other ARVs to treat HIV-1 infection in adults and pediatric patients weighing at least 35 kg; and efavirenz, lamivudine, and tenofovir disoproxil fumarate 400 mg/300 mg/300 mg tablets (Symfi Lo), also approved for patients with HIV-1 in adults and pediatric patients weighing at least 35 kg.  

Following FDA approval, Mylan launched Symfi Lo earlier in March and expects Cimduo and Symfi to launch in the second quarter of 2018.