Mylan gets DCGI marketing approval for ARV drug, Avonza

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Mylan Pharmaceuticals, a subsidiary of Mylan N.V. has received marketing authorization from the Drug Controller General of India (DCGI) for its antiretroviral (ARV) drug Avonza (TLE400). The drug is a fixed-dose (FDC) combination comprised of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate tablets, 400 mg/300 mg/300 mg, recommended by the World Health Organization (WHO) as an alternative first-line regimen for people being treated for HIV/AIDS.
 
Commenting on the launch, Rajiv Malik, president, Mylan said, that developing Avonza and bringing it to patients with HIV in India is a continuation of our strong and sustained commitment to expanding access to affordable, high quality ARVs. Avonza will be available to patients at a cost that is lower than that of other current first-line ARVs.
 
What’s more, Mylan is the first to offer this combination in India, making it another example of the innovative spirit that runs throughout our company to adapt our medicines, accelerate access and improve treatment outcomes, he added.
 
In April 2017, the Union ministry of health launched the Test and Treat Policy for HIV; anyone testing positive for HIV will get antiretroviral therapy irrespective of CD4 count or clinical stage.
 
Mylan’s Avonza also is another step the company is taking to help India meet its sustainable development goal of ending AIDS by 2030.

Globally, Mylan supplies life-saving ARVs to nearly 50 per cent of patients being treated for HIV/AIDS in more than 100 developing countries. The company’s comprehensive ARV portfolio includes 14 active pharmaceutical ingredients and 50 finished dosage forms in first-line, second-line and pediatric formulations.

Source-pharmabiz.com

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