FDA approves first generic of drug for prevention of HIV and to treat HIV-1- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

On June 8, 2017, the U.S. Food and Drug Administration approved the first generic version of Truvada for the treatment of 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.
PrEP may be part of a comprehensive HIV prevention strategy that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk reduction counseling. As part of PrEP, HIV-uninfected individuals who are at high risk of sexually acquired HIV infection take antiretroviral medication daily to try to lower their chances of becoming infected with HIV if they are exposed to the virus.
The most common side effects reported by HIV-1 infected individuals using emtricitabine and tenofovir disoproxil fumarate in clinical trials included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. HIV-1 uninfected individuals taking Truvada for PrEP reported headache, abdominal pain, and decrease of weight.
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 fumaratemust 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. SearchDrugs@FDA for drug labels of FDA approved drug products.
Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. The full list of first generic drug approvals can be viewed here.