Generic HIV Drug Gets FDA Approval

The first generic version of emtricitabine and tenofovir disoproxil fumarate (Truvada), 200 mg/300 mg, has been approved by the FDA after it was determined to be bioequivalent to the reference product.

The newly approved drug is indicated to treat HIV in combination with other antiretroviral agents in adults and pediatric patients. It is also indicated for pre-exposure prophylaxis (PrEP) to prevent the virus in high-risk adults.

Emtricitabine and tenofovir disoproxil fumarate must be dispensed with a medication guide for patients, according to an HIV update email from the FDA.

“Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” the email stated. “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.

“Do not initiate emtricitabine and tenofovir disoproxil fumarate for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. Women infected with HIV-1 should be instructed not to breastfeed while taking emtricitabine and tenofovir disoproxil fumarate.”