Mylan N.V sought approval from FDA for NDA for Dolutegravir Tablets

Mylan N.V, which is a global pharmaceutical company asserted receipt of tentative approval from the U.S Food and Drug Administration under the U.S President’s Emergency Plan for AIDS Relief for its New Drug Application for Dolutegravir tablets, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.

Mylan CEO Heather Bresch said “With limited funding, the world needs cost competitive and clinically effective products like this one, and Mylan is proud to work with partners to make it available and help reach the more than 15 million people living with HIV worldwide who still need access to treatment.”

As per the guidelines of the U.S department of Health and Human services, Mylan’s ARV is a once-daily, fixed-dose combination of Dolutegravir, Emtricitabine and Tenofovir Alafenamide, the individual components that make up ViiV Healthcare’s Tivicay and Gilead’s Descovy. Mylan manufactures these products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively. This is the first tentative approval of Tenofovir Alafenamide and comes just two years after the FDA approval of Descovy. The combination of these agents is currently included as a “Recommended Initial Regimen for Most People with HIV”

Mylan is committed to treating HIV/AIDS and has also long been a supporter of the patient community through the sponsorship of free community HIV/AIDS testing and clinical research.