Date: May 29, 2026
Product Approval Details
Lupin Limited announced it has received approval from the United States Food and Drug Administration (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.
Product Specifications and Equivalency
The approved product is bioequivalent to the reference listed drug (RLD), Sutab® Tablets, 1.479 g/0.225 g/0.188 g of Azurity Pharmaceuticals, Inc. Sutab® is a registered trademark of Azurity Pharmaceuticals, Inc.
Market Exclusivity and Manufacturing
Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The product will be manufactured at Lupin's Nagput facility in India.
Therapeutic Indication
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for the cleansing of the colon as a preparation for colonoscopy in adults.
Market Size Information
The reference listed drug Sutab® had an estimated annual sale of USD 132.8 million in the U.S. based on IQVIA MAT March 2026 data.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has 15 manufacturing sites and 7 research centers globally, with over 24,000 professionals.