Mylan gets FDA nod for cost-saving HIV combo

The U.S. FDA approved Mylan’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate), a triple combo once-daily HIV treatment for adult and pediatric patients who weigh at least 88 lbs.

This marks the third HIV approval for Mylan. The approval of Symfi comes after the FDA's recent approval of two Mylan antiretrovirals (ARVs): Cimduo (lamivudine and tenofovir disoproxil fumarate) and Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate).

Efavirenz tablets are a generic form of Bristol-Myers Squibb’s Sustiva. Lamivudine tablets are the generic version of ViiV Healthcare's Epivir.

According to Mylan, all ARV regimens are being offered at a significant discount to the price of competing products to bring cost savings to the $20 billion U.S. ARV market.

Apr 2, 2018

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