FDA grants tentative approval to Mylan’s HIV/AIDS drug: 3 things to know

The Food and Drug Administration awarded tentative approval to Mylan’s antiretroviral drug TLE400.

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Here are three things to know.

1. The FDA approved the drug under the President’s Emergency Plan for AIDS Relief, a federal initiative to combat the global HIV/AIDS epidemic.

2. TLE400 will be used as a first-line treatment regimen for HIV/AIDS patients in developing countries.

3. The World Health Organization recommended the drug as an alternative first-line treatment for HIV-positive adults in 2016.

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