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FDA extends PDUFA deadline for new colonoscopy prep

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The FDA has pushed back the deadline for the new drug application for Plenvu, a pre-colonoscopy cleansing preparation, until May 13, according to a press release issued by the manufacturer, Salix Pharmaceuticals.

Plenvu (NER1006) is a low-volume polyethylene glycol-based bowel preparation designed to provide whole-bowel cleansing, with a focus on the ascending colon, according to the press release. As Healio Gastroenterology and Liver Disease previously reported, the FDA accepted the NDA for Plenvu in July 2017.

The low-volume solution was developed to improve patient acceptability and the effectiveness of colonoscopy procedures. The FDA extended the prescription drug user fee application action date to take more time to review recently provided data it requested from Salix, according to the press release.

Salix licensed Plenvu from Norgine in August 2016 for introduction to the United States market.