Mylan gets tentative approval to distribute HIV/AIDS candidate under special scheme

7 August 2017

American generics drugmaker Mylan (Nasdaq: MYL) has received tentative approval to distribute its HIV/AIDS treatment TLD in developing countries under the US President's Emergency Plan for AIDS Relief (PEPFAR).

The decision means the drug will be made available as a first-line regimen for people being treated for HIV/AIDS in resource-limited countries with high HIV/AIDS prevalence rates, mainly in Africa.

The company has submitted a New Drug Application for TLD, which is a fixed-dose combination therapy including dolutegravir, lamivudine and tenofovir disoproxil fumarate.

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