Lupin gets USFDA tentative nod for Sodium Sulfate, Magnesium Sulfate, Potassium Chloride Tablets
Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Mumbai: Global pharma major Lupin Limited 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 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 (RLD Sutab) had an estimated annual sale of USD 148 million in the U.S. (IQVIA MAT May 2024).
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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
