Global pharma major Lupin Limited has received tentative approval from the US Food and Drug Administration for its new drug application for Dolutegravir Lamivudine and Tenofovir Alafenamide tablets.

The company received approval under the US President’s Emergency Plan for AIDS Relief.

Mr Naresh Gupta, President of API and Global Institution Business, Lupin, said, “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 US FDA’s tentative approval of Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets, which significantly bolsters our HIV portfolio.”

The company is planning a meeting of the board of directors on August 3, 2023, to consider and take on record the unaudited financial results of the company for Q1.

The product will be manufactured at the company’s Nagpur facility.

Hormosan Pharma GmbH, a wholly-owned subsidiary of Lupin in Germany, launched Luforbec 100/6 (beclometasone 100 µg / formoterol 6 µg), a fixed combination in a pressurized metered dose inhaler (pMDI) for the treatment of adult asthma and chronic obstructive pulmonary disease (COPD) on July 21.