FDA tentatively approves Matrix Labs' combination antiretroviral product

PITTSBURGH A subsidiary of a generic drug maker has received tentative approval from the Food and Drug Administration under President Obama's Emergency Plan for AIDS Relief.

Matrix Labs received tentative approval for a combination product of efavirenz (in 600-mg strength), lamivudine (in 300-mg strength) and tenofovir disoproxil fumarate tablets (in 300-mg strength).

Mylan's product represents the first-ever fixed-dose combination of efavirenz, lamivudine and tenofovir disoproxil fumarate and now provides Matrix with numerous tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first- or second-line treatment in adults, the company said. People use second-line therapies if and when they develop resistance to initially prescribed treatments.

Mylan president Heather Bresch said: "This product represents yet another important advance in our continuing fight against the global epidemic of HIV/AIDS. By combining three antiretroviral products into a once-daily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation also adds another affordable option to our large and rapidly growing portfolio of life-sustaining ARV products."