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Mylan Pharmaceuticals Pvt Ltd, a subsidiary of Mylan N.V. has received marketing authorisation from the Drug Controller General of India (DCGI) for its antiretroviral (ARV) drug Avonza.
Avonza ((TLE400) is a fixed-dose combination comprised of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate tablets recommended by the World Health Organization (WHO) as an alternative first-line regimen for people being treated for HIV/AIDS.
Commenting on the launch, Mylan President Rajiv Malik said: "Avonza will be available to patients at a cost that is lower than that of other current first-line ARVs. Mylan is the first to offer this combination in India.’’
In April 2017, the Health Ministry in India launched the Test and Treat Policy for HIV; anyone testing positive for HIV would get antiretroviral therapy irrespective of the CD4 count or clinical stage.
Globally, Mylan supplies life-saving ARVs to nearly 50 per cent of patients being treated for HIV/AIDS in more than 100 developing countries. Its ARV portfolio includes 14 active pharmaceutical ingredients and 50 finished dosage forms in first-line, second-line and paediatric formulations.
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