FDA approves first generic version of Truvada for HIV
The drug is indicated for use in combination with other antiretroviral agents for the treatment of pediatric and adult patients with HIV-1.
The Food and Drug Administration (FDA) has approved Teva's Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg, the first generic version of Gilead's Truvada 200mg/300mg. Teva's product was determined to be bioequivalent and therapeutically equivalent to the reference drug.
Truvada combines emtricitabine and tenofovir disoproxil fumarate, both nucleoside analogue reverse transcriptase inhibitors. It is indicated for use in combination with other antiretroviral agents, for the treatment of pediatric and adult patients (weighing ≥17kg) with HIV-1, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV in high-risk adults. Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to patients confirmed to be HIV-negative immediately prior to initial use and periodically during use.
Truvada is also available as 100mg/150mg, 133mg/200mg, and 167mg/250mg strength tablets in 30-count bottles.
- US Food and Drug Administration. HIV Update: Approval of Generic Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg [press release]. Published June 9, 2017. Accessed June 9, 2017.