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Lupin bags tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets to control HIV infections
Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) 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, the company stated.
The human immunodeficiency virus (HIV) targets the immune system and weakens people's defense against many infections and some types of cancer that people with healthy immune systems can more easily fight off.
Commenting on the same, 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."
Read also: Lupin bags USFDA nod for Dolutegravir, Rilpivirine tablets to treat HIV infection
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751