Health Canada has given Mylan final approval for the following generic antiretroviral medicines:
- Mylan-Emtricitabine/Tenofovir Disoproxil Fumarate 200 mg/300 mg (an alternative to Truvada);
- Mylan-Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600 mg, 200 mg, and 300 mg (an alternative to Atripla); and
- Mylan-Tenofovir Disoproxil 300 mg (an alternative to Viread)
“Mylan has a strong and sustained commitment to expanding access to treatment for HIV/AIDS and other diseases around the world,” said Mylan Chief Commercial Officer Tony Mauro. “More than 40% of people worldwide being treated for HIV/AIDS with an antiretroviral depend on a Mylan product every day, and we're proud to further expand access to such medicines in Canada.”
According to a statement from the company, around 37 million people around the world are living with AIDS. Because of a $250-million investment to expand its antiretroviral (ARV) production capacity, the company can now produce 4 billion ARV tablets and capsules a year.
Mylan’s Truvada alternative is indicated in combination with other ARV agents for the treatment of HIV-1 in adults. The Atripla alternative is indicated for use on its own, or in combination with other treatments for the treatment of HIV-1 in adults.
The Viread alternative is indicated in combination with other ARV agents for the treatment of HIV-1 infection in patients aged 12 years old and older. It is also indicated for the treatment of chronic hepatitis B infection in adults.
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Mylan Pharmaceuticals ULC, a subsidiary of Mylan NV, has announced the Canadian launch of three generic products used to treat HIV.