FDA approves first generic of drug for prevention of HIV and to treat HIV-1- Drug Information Update.
The U.S. Food and Drug Administration has 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, must be used as directed by the physician, and should be taken by mouth only.
More information on emtricitabine and tenofovir disoproxil fumarate may be found within the drug label, according to the FDA.
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.