Medication Monitor



Generic Name (Trade Name—Company)
Notes
May 14, 2018

Polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution

(Plenvu—Valeant/Salix)
Lower-volume bowel cleansing prep for colonoscopies receives FDA approval

Salix Pharmaceuticals announced FDA approval of polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution, a lower-volume (1L) polyethylene glycol based (PEG) bowel preparation, under the trade name Plenvu.

Plenvu is the lowest, total-volume preparation bowel cleanser available in the United States, according to Salix.

Approval was based on multiple Phase III clinical trials, including the NOCT study, which compared Plenvu versus a trisulfate bowel cleansing solution (Suprep) using a two-day split-dosing regimen in adults. Both primary endpoints were met, achieving noninferior overall bowel cleansing success and "excellent plus good" cleansing of the ascending colon.

Plenvu is also the only FDA-approved bowel cleanser to offer split dosing on the same day as the colonoscopy procedure.