Mylan Gets FDA's Tentative Approval For "TLD" Under PEPFAR For HIV/AIDS

(RTTNews) - Mylan N.V. (MYL) announced Monday the receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief or PEPFAR for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg or TLD.

TLD, an antiretroviral fixed-dose combination, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS.

Mylan said its TLD combines molecules from three originator medicines - ViiV Healthcare's Tivicay (via a license through the Medicines Patent Pool) and Epivir and Gilead Science's Viread.

Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS

Mylan President Rajiv Malik said, "Our innovative TLD is a new medicine that will be available specifically to patients in the developing world being treated for HIV/AIDS. We know the challenges they face accessing high quality, affordable ARVs. That's why our scientists worked diligently to develop a medicine that combines three of the leading first-line regimens into a new, smaller tablet that patients have to take only once each day."