Mylan Leads Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Mylan.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday August 9, 2017 to Tuesday August 15, 2017.

Mylan Launches Three Antiretroviral Drugs in Canada
Mylan Pharmaceuticals, a subsidiary of Mylan, has launched three generic products indicated for treating HIV-I infection. Mylan received final approval from Health Canada, the national pharmaceutical regulatory authority in Canada.

One of the products is emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg, a generic alternative to Gilead Sciences’ Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg). Gilead Sciences’ Truvada had 2016 sales of nearly $3.6 billion.

The second product is emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg, which is indicated in combination with other antiretroviral agents for treating HIV-1 in adults.

The other two products include tenofovir disoproxil 300 mg, a generic alternative to Gilead Sciences’ Viread (tenofovir alafenamide), and efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg, 200 mg, and 300 mg, a generic alternative to Bristol-Myers Squibb’s Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate).

Mylan’s tenofovir disoproxil 300 mg is indicated for treating HIV-1 in combination with other antiretroviral agents in patients 12 years of age and older and for treating chronic hepatitis B in adults.

Mylan’s efavirenz/emtricitabine/tenofovir disoproxil fumarate 600 mg, 200 mg, and 300 mg is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for treating HIV-1 in adults.

Mylan has invested $250 million in expanding its antiretroviral (ARV) production capacity, enabling the company to produce 4 billion ARV tablets and capsules annually

Source: Mylan

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