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# Teva Gains Approval for 1st Generic Copy of Truvada
- URL: https://www.fdaweb.com/teva-gains-approval-for-1st-generic-copy-of-truvada/
- Published: 2017-06-09T12:00:00.000Z
- Updated: 2026-09-14T22:28:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138901

FDA has approved a Teva Pharmaceuticals ANDA for the first generic copy of Gilead’s Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for treating HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use, according to the agency. “Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir disoproxil fumarate for PrEP following undetected acute HIV-1 infection,” it says. The product is required to be dispensed with a Medication Guide for patients.