FDA HIV Update: Approval of Generic Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

Content From: FDAPublished: June 29, 20172 min read



Cross-posted from FDA Office of Health and Constituent Affairs 

Editor's Note: Generic drug approval by the FDA allows the generic drug to be marketed in the United States. The manufacturer determines when they will launch the product for marketing.

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 must be used as directed by the physician and should be taken by mouth only. If you have kidney problems, your healthcare provider may tell you to take emtricitabine and tenofovir disoproxil fumarate less often. Do not change your dose or stop taking emtricitabine and tenofovir disoproxil fumarate without first talking with your healthcare provider. Stay under a healthcare provider’s care when taking emtricitabine and tenofovir disoproxil fumarate. 

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.