Following the recent approval received from the United States Food and Drug Administration (U.S. FDA), Lupin today announced the launch of Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the United States. Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity. Tolvaptan Tablets are bioequivalent to Jynarque® Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). |