Global pharma major Lupin Limited on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets.
The tentative approval has been granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).
This product would be manufactured at Lupin’s Nagpur facility in India.
DETAF would be a welcome new addition to the management of HIV infections and will be available for supplies to low and middle-income countries, the pharma major stated on Tuesday.
“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,” Naresh Gupta, President – API and Global Institution Business, Lupin said in a statement.