RedHill nears NDA for its version of GSK's Zofran

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.

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.

The Israeli biopharmaceutical firm, which mainly focuses on late-stage development of new formulations and combinations of existing drugs, made its...

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