Mylan announced that the Food and Drug Administration (FDA) has approved Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate) 600mg/300mg/300mg tablets as a complete regimen for the treatment of HIV-1 infection in adults and children weighing ≥40kg.

Symfi contains the same triple combination ingredients found in the recently approved and launched Symfi Lo but with a 600mg dose of efavirenz vs 400mg seen in Symfi Lo. In addition, the FDA recently approved Mylan’s Cimduo (lamivudine, tenofovir disoproxil fumarate) 300mg/300mg tablets intended for use with other antiretroviral agents for the treatment of HIV-1 infection in adults and children weighing ≥35kg.

Symfi, a once-daily, single-tablet regimen, consists of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and lamivudine and tenofovir disoproxil fumarate, both nucleo(t)side reverse transcriptase inhibitors. 

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Safety findings from the ENCORE 1 study showed the 600mg combination dose of efavirenz was found to have a slightly higher rate for most adverse events than the 400mg dose including abnormal dreams (11.3% vs 8.7%), insomnia (6.5% vs 6.2%), somnolence (3.9% vs 3.1%), depression (1.6% vs 3.1%), and dizziness (35% vs 27%). 

Both Symfi and Cimduo are anticipated to launch in the second quarter of 2018. Symfi Lo is already available as 400mg/300mg/300mg strength tablets in 30-count bottles. 

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