FDA Approvals, Highlights, and Summaries: Gastroenterology

February 24, 2021

Pizensy (lactitol)

Lactitol exerts an osmotic effect, causing an influx of water into the small intestine that results in a laxative effect in the colon. It is indicated for adults with chronic idiopathic constipation.

Approval was based on data from approximately 800 patients that included a 6-month placebo-controlled trial and a 3-month active-controlled trial with lubiprostone. (Pizensy prescribing information)

Other notable approvals

Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) - Indication for colonoscopy bowel preparation expanded to include children aged 12 years and older

Sutab (sodium sulfate/magnesium sulfate/potassium chloride) - New oral tablet regimen for bowel preparation for colonoscopy

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