FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets

Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from the US Food and Drug Administration (US FDA).

The approval, granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), gives Lupin the green light to manufacture the product at its Nagpur facility in India.

Naresh Gupta, President of API and Global Institution Business at Lupin, expressed his satisfaction with the U.S. FDA’s decision. He stated, “At Lupin, we are unwavering in our commitment to providing affordable and quality treatment options for patients in low and middle-income countries. We are pleased to receive the U.S. FDA’s tentative approval of Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets, which significantly bolsters our HIV portfolio.”

The approval provides a major boost to Lupin’s HIV product range, reinforcing the company’s commitment to affordable healthcare in low and middle-income countries.