Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan

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Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan - Business Standard

Quick Summary:

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator for its generic version of Tolvaptan tablets indicated for a certain type of kidney disease.

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, Lupin said in a regulatory filing.

Commenting on the approval, Lupin CEO Vinita Gupta said,"This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally".