Salix Pharmaceuticals, Inc issued the following announcement on Feb. 9.
Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), and its partner Norgine B.V. ("Norgine") have received notice that the U.S. Food and Drug Administration (FDA) has extended the PDUFA action date for its review of the New Drug Application for PLENVU®* (NER1006) by three months to May 13, 2018. The PDUFA action date has been extended to allow the FDA more time to review additional data that was recently provided at its request.
PLENVU® was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market. Salix and Norgine will continue to work closely with the FDA to support the review of PLENVU®, a next-generation bowel cleansing preparation for colonoscopies.
About PLENVU® (NER1006)
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.
Original source can be found here.
Alerts Sign-up