FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations

Mylan N.V., a global pharmaceutical company, has gained tentative U.S. Food and Drug Administration (FDA) from the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400").
TLE400, an antiretroviral (ARV) fixed-dose combination, was tentatively approved under the President's Emergency Plan for AIDS Relief. Developing countries will now be able to use the drug as a first-line regimen for treating HIV/AIDS patients.
"Mylan has a strong and sustained commitment to expand access to treatment for HIV/AIDS and other diseases in developing countries," Mylan President Rajiv Malik said in a statement. "We have nine independent sites engaged in the production and supply of ARV products, ensuring multiple redundancies so we can maintain continuous supply."
Mylan noted in its press release that a vast majority of the 37 million people living with HIV/AIDS across the globe live in developing countries.
"TLE400 is another example of our work to partner with leading global health organizations to innovate and adapt our medicines to meet the unique needs of people living in these settings, in order to accelerate access and to improve treatment outcomes," Malik said