Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets. This product would be manufactured at Lupin’s Nagpur facility in India.
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries.
Commenting on the same, Mr. Naresh Gupta, President - API and Global Institution Business, Lupin said, “We are committed to providing affordable and quality treatment options to patients in low- and middle- income countries. We are pleased that U.S. FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio.”
