Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
Tolvaptan Tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company.
Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity.
This product will be manufactured at Lupin's Nagpur facility in India and will be launched soon.
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
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