RedHill nears NDA for its version of GSK's Zofran
This article was originally published in Scrip
Executive Summary
RedHill Biopharma has said it intends "to request a pre-NDA meeting with the FDA in the coming weeks to discuss a US NDA marketing approval application for RHB-102", its once-daily controlled release formulation of the antiemetic, ondansetron, for the prevention of nausea and vomiting in cancer patients.