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FDA Accepts NDA for New Colonoscopy Bowel Prep
FDA accepted a New Drug Application for PLENVU, lower-volume polyethylene glycol based bowel preparation developed by Salix Pharmaceuticals to help provide complete bowel cleansing with an additional focus on the ascending colon, according to a press release.
If approved, PLENVU will provide patients with the lowest total volume of solution for an FDA-approved bowel cleanser in the market, allowing patients to avoid high preparation volumes that often prevent them from fully completing their regimen. The low-volume solution used in PLENVU will improve patient acceptability while also leading to more effective colonoscopy procedures that can detect colon cancer and optimize bowel surveillance through successful bowel cleansing.
“Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps,” Mark McKenna, senior vice president and general manager at Salix Pharmaceuticals, said in the release. “If approved, PLENVU may enhance bowel cleansing and the overall bowel prep experience relating to a colonoscopy.”
Disclosure: McKenna is senior vice president and general manager at Salix Pharmaceuticals.