Drug maker Lupin Ltd confirmed on Tuesday that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of a combination HIV treatment.CompanyValueChange%ChangeThe company has received tentative approval from the US Food and Drug Administration (USFDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets, it said in a statement.The company’s product has been found to be therapeutically equivalent to the reference listed drug Symtuza tablets, 800 mg/150 mg/200 mg/10 mg of Janssen Products, LP, it added.
As per the IQVIA MAT December 2024 data, Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets had estimated annual sales of USD 1,374 million in the US.Lupin is the exclusive first-to-file applicant for this product, which will be manufactured at its Nagpur facility in India.The company said it had not separately disclosed the approval as it did not qualify as a material event under SEBI’s listing regulations. “The company makes prompt disclosures, as and when any event or information is considered material or warrants such disclosure,” Lupin said in the filing.Shares of Lupin ended 3.5% higher at ₹2,103 apiece on BSE.Also Read: Birla Corp Q3 results: Net profit declines 72% on lower cement prices, cement sales volume up 7%
