First generic version of Truvada approved for pre-exposure prophylaxis
By MedPage Today Staff
June 09, 2017
Individuals at risk for contracting HIV can now access a generic version of emtricitabine and tenofovir disoproxil fumarate, known as Truvada in branded form, that can be used to prevent infection, the FDA announced.
The generic product, made by Teva, is approved both for treatment of active HIV infection and for pre-exposure prophylaxis, or PrEP, the agency said. It’s the first generic emtricitabine-tenofovir combination to win FDA approval.
Label information and warnings are the same as for branded Truvada; the generic must be dispensed with a patient medication guide that explains dosing and potential adverse effects.