Lupin receives tentative nod from FDA for DETAF
DETAF would be used for the management of HIV infections and will be available for low- and middle-income countries.
Lupin has received the Food and Drug Administration’s tentative nod for dolutegravir, emtricitabine and tenofovir alafenamide 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- and middle-income countries, the company said.
[Read more: Lupin receives FDA OK for generic Banzel]
Naresh Gupta, president of 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 the FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio.”