Lupin launches generic version of kidney disorder treatment drug in US
Pharma major
Lupin Ltd
on Tuesday said it has launched the generic version of Tolvaptan tablets used to slow kidney function decline in the
US market
, following the recent approval received from the country's health regulator. The company has launched Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the US, after receiving the approval from the
US Food and Drug Administration
(
USFDA
).
#Operation Sindoor
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"Lupin holds the exclusive first-to-file status for this product and will have 180-day
generic drug
exclusivity,"
Lupin
said in a statement.
Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added.
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Lupin
CEO
Vinita Gupta
said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
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