FDA Lifts Future REMS Burden On Antiretroviral Leaders

As generics of Gilead’s Truvada combination antiretroviral reach the US market, their manufacturers will no longer have to provide risk-mitigation education.

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Educational burdens have been lifted on generics of Truvada likely to reach the US market from next year • Source: Shutterstock

Four of the leading lights in the US generics industry – Amneal, Aurobindo, Mylan and Teva – have seen their educational burden on antiretrovirals lessened after the US Food and Drug Administration eliminated the risk evaluation and mitigation strategy for Gilead’s Truvada emtricitabine/tenofovir disoproxil fumarate and its four approved generics.

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