Lupin bags USFDA nod for Emtricitabine, Tenofovir Disoproxil Fumarate Tablets to treat HIV
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.
Mumbai: Global pharma major, Lupin Limited, has recently announced that the company has received approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the United States Food and Drug Administration (USFDA).
The product is 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 USD 2.1 billion in the U.S. (IQVIA MAT March 2021).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
