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FDA rejects regulatory approval application for Rezonic


LONDON The Food and Drug Administration rejected a regulatory approval application for a drug to prevent nausea and vomiting resulting from chemotherapy and surgical operations.

GlaxoSmithKline announced that it had received a complete response letter from the FDA’s Center for Drug Evaluation and Research for the drug Rezonic (casopitant mesylate).

The FDA issues a complete response letter when it rejects a regulatory approval application due to remaining questions or problems in the data used to support it.

GSK filed for approval of Rezonic last May.

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