Lupin receives tentative approval from U.S. FDA for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride tablets

Lupin today announced that it has received tentative 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, to market a generic equivalent of Sutab Tablets, 1.479 g/0.225 g/0.188 g, of Braintree Laboratories.

“Lupin is the exclusive first-to-file for this product and may be eligible for 180-day exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India,” the statement informs.

Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets (RLD Sutab) had an estimated annual sale of USD 148 million in the U.S. (IQVIA MAT May 2024).