USFDA29 May 2026, 07:14 pm
Lupin Gets US FDA Nod for Sodium Sulfate, Magnesium Sulfate Tablets
AI Summary
Lupin Ltd. has received approval from the U.S. FDA for its Abbreviated New Drug Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g, bioequivalent to Sutab® Tablets of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The product, indicated for colon cleansing, will be manufactured at Lupin’s Nagpur facility in India. The annual sale for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab®) was USD 132.8 million in the U.S. (IQVIA MAT March 2026).
Key Highlights
- Lupin receives U.S. FDA approval for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets.
- Lupin is the exclusive first-to-file and eligible for 180-day generic drug exclusivity.
- The approved drug is bioequivalent to Sutab® Tablets of Azurity Pharmaceuticals, Inc.
- The product will be manufactured at Lupin’s Nagpur facility in India.
- Annual sales for the reference drug were USD 132.8 million in the U.S.
Price Impact
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