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# User Fee Review Extended on Salix Bowel Cleaner
- URL: https://www.fdaweb.com/user-fee-review-extended-on-salix-bowel-cleaner/
- Published: 2018-02-09T12:00:00.000Z
- Updated: 2026-09-14T23:21:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140725

FDA has extended by three months the user fee review of Salix Pharmaceuticals’ NDA for Plenvu (NER1006). The new review target date is 5/13, and it gives agency reviewers more time to review additional data that were recently provided at FDA’s request.

Plenvu is an investigational, novel, low-volume polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. It is being developed to support improved patient acceptability and compliance, and to contribute to effectiveness of colonoscopy procedures at detecting colon cancer by “optimized bowel surveillance through effective bowel cleansing,” the company says.