US FDA Gave Tentative Approval to Lupin’s DETAF Tablets


The major pharmaceutical company made the announcement that its new drug application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide (DETAF) tablets had received preliminary approval from the US Food and Drug Administration (USFDA).

DETAF tablets were tentatively approved by the US Food and Drug Administration as part of the President’s Emergency Plan to Fight AIDS (PEPFAR). At Lupin’s Nagpur facility in India, this product would be made.

Lupin is committed to providing affordable and quality treatment options to patients in low- and middle-income countries, said Naresh Gupta, president of Lupin’s API and Global Institution Business. Naresh Gupta added that they are pleased that DETAF, which will significantly expand their HIV portfolio, has been tentatively approved by the FDA in the United States.

According to Lupin’s statement, the DETAF would be a welcome addition to the treatment of HIV infections and will be available for supplies in low- and middle-income countries.

Lupin is a multinational pharmaceutical company driven by innovation that produces, develops, and markets a wide variety of generic and brand-name formulations, biotechnology products, and active pharmaceutical ingredients (APIs) worldwide.

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In comparison to its net loss of Rs 2,098.04 crore in Q2 FY22, the company reported a consolidated net profit of Rs 129.73 crore in FY23. In Q2 FY23, net sales increased by 2.2% to Rs 4,091.16 crore, up from Rs 4,003.42 crore in Q2 FY22.