The first generic version of the HIV drug Truvada has received approval from the Food and Drug Administration.
The 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,” said a statement from the FDA.
Common side effects among HIV-1 infected people taking the generic PrEP 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 gave this recommendation: Women with HIV-1 shouldn’t breastfeed while taking the medication.
Generic PrEP Receives FDA Approval
