Lupin secures tentative U.S. FDA approval for generic HIV treatment under PEPFAR

Global pharma major Lupin (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovy Tablets, 200 mg/25 mg, of Gilead Sciences, Inc. 

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries. Emtricitabine and Tenofovir Alafenamide Tablets are indicated to treat or prevent HIV-1 infection in adults and children who weigh at least 35 kg.

Naresh Gupta, President – API and Global Institution Business, Lupin said, “Lupin is committed to offering affordable, quality treatments for patients. The tentative approval from the U.S. FDA for our Emtricitabine and Tenofovir Alafenamide Tablets significantly enhances our HIV medicine offering.”