FDA Approves Generic Truvada For HIV Treatment And PrEP

In a move that has taken HIV advocates by surprise and stewed considerable confusion, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.

However, Gilead insisted in a statement, “A generic version of Truvada will not be immediately available. It’s important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval.”