Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (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 Inc. 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.
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 (Sutab) had an estimated annual sale of USD 148 million in the US (IQVIA MAT May 2024).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
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