HealthDay News — The US Food and Drug Administration has approved the first generic version of the HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate).
The generic drug is approved 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,” according to the FDA.
Common side effects among HIV-1 infected people using the drug in clinical trials included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. HIV-free people taking Truvada for PrEP reported headache, abdominal pain, and weight loss.
When the generic form is used to prevent HIV infection, it “must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” the FDA said.
The agency also said that doctors should tell women with HIV-1 not to breastfeed while taking the drug.
“First Generic Drug Approvals.” US Food & Drug Administration. Updated June 13, 2017. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsare DevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default. htm. Accessed June 13, 2017.