US EditionLupin receives US FDA approval for generic Tolvaptan Tablets - Express Pharma
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Lupin receives US FDA approval for generic Tolvaptan Tablets - Express Pharma
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tolvaptan Tablets in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. The approved product is bioequivalent to Jynarque Tablets of the same strengths, originally developed by Otsuka Pharmaceutical Company Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days o…
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