BRIEF—Lupin's generic Truvada approved by FDA

Indian pharma major Lupin Limited has announced that it has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200mg/300mg, from the US Food and Drug Administration, to be marketed as a generic equivalent of Gilead Sciences’ Truvada.

The product will be manufactured at Lupin’s facility in Nagpur, India.

The product is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

It is also used for pre-exposure prophylaxis (PrEP) to reduce the

Truvada had estimated annual sales of $2.1 billion in the USA (IQVIA MAT March 2021).