Mylan has reported that Matrix Laboratories (Matrix) has received tentative approval from FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR). FDA approved its Abbreviated New Drug Application (ANDA) for a fixed-dose combination (FDC) of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg.
The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate FDC is the generic version of Gilead Sciences’ Atripla Tablets, which are indicated for the treatment of HIV-1 infection in adults.
Heather Bresch, president at Mylan said: This critical approval only further strengthens Mylan and Matrix’s efforts to expand access to life-saving, affordable AIDS treatments for people living with HIV/AIDS in developing countries. Matrix’s generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment.
Our commitment to growing Matrix’s ARV (antiretroviral) franchise goes hand-in-hand with our desire to raise the standard of care in developing countries to the levels available in countries like the US, he added.