Lupin gets USFDA’s nod for Emtricitabine, Tenofovir Disoproxil Fumarate Tablets

07 Jun 2021 Evaluate

Lupin has received approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Truvada Tablets, 200 mg/300 mg, of Gilead Sciences, Inc. The product will be manufactured at Lupin’s facility in Nagpur, India.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. It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (RLD: Truvada) had estimated annual sales of $2.1 billion in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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