FDA just approved generic version of Truvada, both to treat and prevent HIV

 

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The U.S. Food and Drug Administration (FDA) just approved the generic version of antiretroviral drug tenofovir disoproxil fumarate/emtricitabine commonly known by brand name Truvada, Gilead Sciences. The approval allows Teva Pharmaceutical to produce first generic version of the drug, which is used as part of treatment plan for HIV as well as pre-exposure prophylaxis (PrEP).

The drug is marketed as fixed dose 200 mg/300 mg combo tablet.

Jeffrey S. Murray, MD, MPH, deputy director of the Division of Anti-Viral Products at the FDA said “Yes, the first generic for Truvada has been approved and will now be available in the U.S. Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many.”

The generic version of the drug is already available outside US. It is made in India by Strides Arcolab Limited to be used outside US.

The indication listed in FDA release is “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.”

This move by US FDA has huge implications in terms of cost saving. The branded drug which was originally costing someone around $15000 a year, could be reduced to $70 a month, or around $850 a year.

The FDA release can be accessed here.

Here is a video about Truvada, when it was cleared by FDA in 2012.