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Lupin Receives U.S. FDA Approval For Generic Sutab Tablets

May 30, 2026 — 12:12 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - Lupin Limited announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.

The approved product is bioequivalent to the reference listed drug (RLD), Sutab Tablets of Azurity Pharmaceuticals, Inc. Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity. Manufacturing will take place at Lupin's Nagpur facility in India.

Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing the colon as preparation for colonoscopy in adults. Sutab® had estimated annual U.S. sales of USD 132.8 million as of March 2026, according to IQVIA.

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