Cardiome, development partner meet with FDA, to follow up on refusal-to-file letter for RSD1235

By Lisa Kerner

Charlotte, N.C., July 7 - Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. met with the Food and Drug Administration to discuss issues raised in the refusal-to-file letter received in response to the companies' New Drug Application for RSD1235 (iv), an Investigational New Drug for the acute conversion of atrial fibrillation.

Cardiome said the companies are conducting a comprehensive re-review of the NDA documents and plan to resubmit an amended NDA.

Vancouver, B.C.-based Cardiome is a cardiovascular drug development company.

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