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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.

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