Lupin Limited today announced that it 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 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).
