Lupin Receives U.S. FDA Approval For Generic HIV Drug
Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment or prevention of HIV-1 infection in adults and children weighing at least 35 kg
Global pharma major Lupin (Lupin) 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.
In a press statement on Thursday, the company informed that this approval allows Lupin to market a generic equivalent of Descovy Tablets, 200 mg/25 mg, developed by Gilead Sciences, Inc.
The approved product will be manufactured at Lupin’s Nagpur facility in India and supplied to low and middle-income countries. Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment or prevention of HIV-1 infection in adults and children weighing at least 35 kg, the press statement from the company added.
Naresh Gupta, President - API and Global Institution Business at Lupin, commented, “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.”
