Research & Development
Salix Pharmaceuticals & Norgine BV partnership receives notice from the US FDA for extended PDUFA action date for PLENVU NDA
12 February 2018 -

Salix Pharmaceuticals Ltd and its partner Norgine BV on Friday jointly announced the receipt of notice from the US Food and Drug Administration (FDA) for the extended PDUFA action date for its review of the New Drug Application for PLENVU (NER1006) for bowel cleaning.

The partnership's PDUFA action date has been extended by three months to 13 May 2018 to allow the USD FDA more time to review additional data that was recently provided at its request.

In August 2016, PLENVU was licensed by Salix from Norgine for the product's launch in the US market. The partnership will continue to work closely with the US FDA to support the review of PLENVU, a next-generation bowel cleansing preparation for colonoscopies.

According to the companies, PLENVU (NER1006) is an investigational, novel, low-volume (1L) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing,with an additional focus on the ascending colon. This low-volume solution is developed not only to support improved patient acceptability and compliance, but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer by optimized bowel surveillance, through effective bowel cleansing.

Salix Pharmaceuticals Ltd is a specialty pharmaceutical company committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE:VRX)(TSX:VRX).