www.fdanews.com/articles/175612-fda-gives-thumbs-up-to-gileads-odefsey
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FDA Gives Thumbs Up to Gilead’s Odefsey
March 7, 2016
The FDA has approved Gilead’s second TAF-based single-tablet regimen Odefsey for the treatment of HIV infection.
Odefsey is a single-tablet combination of emtricitabine, rilpivirine and tenofovir alafenamide — or TAF — and is designed to treat HIV-1 in patients 12 years of age or older with no history of antiretroviral treatment.
The approval is part of a development and commercialization agreement between Gilead and Janssen established in 2009. Gilead contributed emtricitabine and tenofovir alafenamide, and Janssen contributed rilpivirine.