FDA/CDC

FDA approves generic version of HIV drug Truvada

Publish date: June 9, 2017
By
Richard Pizzi

 

The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.

Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.

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According to the FDA press release, emtricitabine and tenofovir disoproxil fumarate – when used for PrEP – must “only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” as drug-resistant HIV-1 variants have been identified with the use of Truvada for PrEP following undetected acute HIV-1 infection.

Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.

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