FDA Approves Truvada Generic for HIV Treatment

The US Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets for the treatment of HIV-1.

The generic formulations are products of Teva Pharamceuticals USA, and will now be available in 200 mg and 300 mg tablets and have been determined to be both bioequivalent and therapeutically equivalent to Truvada, a name brand prescription medicine used to help at-risk patients reduce the risk of contracting HIV-1.

The drug is indicated for the treatment of HIV-1 in combination with other antiretroviral agents in adults and pediatric patients weighing at least 17kg (37.5lbs), and for pre-exposure prophylaxis (PrEP) in combination with safe-sex practices.

Emtricitabine and tenofovir disoproxil fumarate used for PrEP should only be prescribed to patients who have been 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.

Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate.