USFDA approves Lupin drug for HIV-1 infection
Mumbai: Global pharma major Lupin Limited today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg.
The approval granted for marketing of a generic equivalent of Descovy Tablets, 200 mg/25 mg of Gilead Sciences, Inc.
"Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity," the Company stated.
This product will be manufactured at Lupin’s Nagpur facility in India.
Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment of HIV-1 Infection and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in adults and adolescents.
Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its ANDA for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
Read also: Lupin bags tentative USFDA nod for Raltegravir Tablets for HIV-1 infection
HIV-1 Infection refers to a chronic, progressive disease caused by the Human Immunodeficiency Virus type 1 (HIV-1), which primarily attacks the immune system, particularly CD4+ T-cells. Over time, the depletion of these immune cells compromises the body’s ability to fight infections and diseases, potentially leading to Acquired Immunodeficiency Syndrome (AIDS).
Emtricitabine and Tenofovir Alafenamide Tablets (RLD Descovy) had estimated annual sales of USD 3,556 million in the U.S. (IQVIA MAT October2024).
