ARTICLE | Clinical News

FDA prolongs review of Valeant's bowel cleansing agent

February 16, 2018 7:34 PM UTC

The Salix Pharmaceuticals Ltd. subsidiary of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) and partner Norgine B.V. (Amsterdam, the Netherlands) said FDA extended by three months its review of an NDA for Plenvu (NER1006) for bowel cleansing. The new PDUFA date is May 13.

Salix said FDA extended the review after the company submitted additional data at the agency's request...