FDA tentatively approves Mylan’s generic HIV treatment

PITTSBURGH The Food and Drug Administration has given tentative approval to a generic drug for treating HIV under the President’s Emergency Plan for AIDS Relief.

Generic drug maker Mylan announced Tuesday the tentative approval of subsidiary Matrix Labs’ fixed-dose combination tablets containing 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. The drug is a generic version of Gilead Sciences’ Atripla tablets, used to treat HIV infection in adults.

“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,” Mylan president Heather Bresch said in a statement. “Matrix’s generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment.”

Atripla had sales of $1.6 billion for the 12 months ending June 30, according to IMS Health data.