Lupin gets USFDA nod for generic drug to treat HIV infection

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Global pharma major Lupin Limited has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Truvada tablets, 200 mg/300 mg, of Gilead Sciences, Inc.

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The product will be manufactured at Lupin’s facility in Nagpur, India.. It is also used for for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Emtricitabine and tenofovir disoproxil fumarate tablets had estimated annual sales of US$ 2.1 billion in the US, according to IQVIA MAT March 2021)

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