Lupin gets tentative FDA nod for its HIV combo DETAF and Juluca generic

Mumbai, India-based generic drugmaker Lupin Limited (BSE: 500257) revealed that it has received tentative approval from Food and Drug Administration (FDA), under the US President’s Emergency Plan for AIDS Relief (PEPFAR), for its New Drug Application for dolutegravir, emtricitabine and tenofovir alafenamide (DETAF) tablets.

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries, the Indian drugmaker noted, adding that this product would be manufactured at Lupin’s Nagpur facility in India.

Commenting on the same, Naresh Gupta, president API and global institution business at Lupin, said: “We are committed to providing affordable and quality treatment options to patients in low- and middle-income countries. We are pleased that US FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio.”