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.

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-07-16 09:57 GMT   |   Update On 2024-07-16 14:45 GMT
Advertisement

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).

Read also: Lupin gets USFDA nod for Topiramate Extended Release Capsules for seizures

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.

Read also: Lupin divests US Commercial Women Health Specialty Business to Evofem Biosciences for nearly USD 84 million

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News