June 9, 2017
On June 8, 2017, the Food and Drug Administration approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada Tablets, 200 mg/300 mg.
The drug is indicated for the treatment of HIV-1, in combination with other antiretroviral agents in adults and pediatric patients weighing at least 17 kg, 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 must be dispensed with a Medication Guide for patients, which provides important information about the medication's use and risks.
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. 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. Do not initiate emtricitabine and tenofovir disoproxil fumarate for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.
Women infected with HIV-1 should be instructed not to breastfeed while taking emtricitabine and tenofovir disoproxil fumarate.
More information on emtricitabine and tenofovir disoproxil fumarate may be found within the drug label at Drugs@FDA.
The generic formulation is a product of Teva Pharmaceuticals USA.
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