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
Picture: Pixabay

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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