Lupin Limited, a global pharmaceutical company, announced today that the US Food and Drug Administration (FDA) has tentatively approved its Abbreviated New Drug Application for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg and 25 mg. This approval is part of the US President's Emergency Plan for AIDS Relief (PEPFAR), and it allows Lupin to market a generic equivalent of Gilead Sciences, Inc.'s Descovy Tablets, 200 mg/25 mg.

Adults and children weighing at least 35 kg receive prescriptions for Emtricitabine and Tenofovir Alafenamide Tablets to treat or prevent HIV-1 infection. These tablets operate by lowering the amount of HIV in the blood, allowing the immune system to act more effectively. However, potential adverse effects include headaches, nausea, exhaustion, and, in rare cases, serious liver damage and lactic acidosis.

Lupin's Nagpur facility in India will manufacture and distribute the product to low- and middle-income countries. Mr. Naresh Gupta, the President of API and Global Institution Business at Lupin, reaffirmed the company's dedication to providing patients with affordable, high-quality medications. The provisional approval by the US FDA for our Emtricitabine and Tenofovir Alafenamide Tablets significantly expands our HIV treatment portfolio."

This approval is a critical step toward offering accessible HIV treatment alternatives to those in need across several locations.