Teva gets FDA approval for first generic of Truvada
SILVER SPRING, Md. — The Food and Drug Administration on Friday announced its approval of Teva’s abbreviated new drug application the first generic of Gilead’s Truvada (emtricitabine and tenofovir disoproxil).
The drug is indicated both as a treatment for HIV-1 in combination with other antiretroviral drugs and for pre-exposure prophylaxis to prevent sexually acquired HIV infection in combination with safer sex practices.
According to the QuintilesIMS Institute’s 2017 Medicine Use and Spending report, Truvada had $3.1 billion in sales on an invoice price basis in 2016, ranking 17th among the top 20 medicines in the U.S. based on invoice spending. The drug has seen more than $2 billion in invoice spending since 2012, with 2016 marking its highest sales between 2012 and 2016.