Sutab FDA Approval History
FDA Approved: Yes (First approved November 10, 2020)
Brand name: Sutab
Generic name: sodium sulfate, magnesium sulfate, and potassium chloride
Dosage form: Tablets
Company: Sebela Pharmaceuticals, Inc.
Treatment for: Bowel Preparation
Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) is an osmotic laxative in a tablet formulation indicated for cleansing the colon in preparation for colonoscopy in adults.
- Sutab provides an alternative to liquid colonoscopy preparations, which many patients find difficult to take because of the large volume of liquid required, and the unpleasant taste.
- Sutab is taken as two doses of 12 tablets: the first dose on the evening before the colonoscopy, and the second dose on the morning of the colonoscopy. Water must be consumed with each dose of Sutab, and additional water must be consumed after each dose.
- Patients taking Sutab should contact their healthcare provider if they develop significant vomiting or signs of dehydration, or if they experience cardiac arrhythmias or seizures. Common adverse reactions include nausea, abdominal distension, vomiting and upper abdominal pain.
Development Timeline for Sutab
|Nov 10, 2020||FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation|
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