Salix to file budesonide foam NDA on Phase III success
This article was originally published in Scrip
Executive Summary
Salix Pharmaceuticals plans to submit a new drug application (NDA) to the US FDA by the end of September for budesonide foam in the treatment of active mild-to-moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS) based on positive results from two pivotal Phase III clinical trials.