Global pharma company Lupin Ltd. on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its new drug application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide (DETAF) tablets that manage HIV infections.
The company said that it has received the tentative nod from the US drug regulator under the US President’s Emergency Plan for AIDS Relief (PEPFAR).
Lupin further said that DETAF tablets, which would be manufactured at the company’s Nagpur facility, would be a “welcome new addition” in the management of HIV infections and would be available for supplies to low- and middle-income countries.
Earlier this month, Lupin announced that it had received tentative approval from the USFDA for its abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg.
The tablets were the generic equivalents of Juluca Tablets, 50 mg/25 mg of ViiV Healthcare Company, with estimated annual sales of $666 million in the US, according to IQVIA.
Juluca Tablets are used for the treatment of HIV infection in adults. The drug controls the infection and helps to decrease the virus in the body.
