Business Update

Cardiome and Astellas Pharma US, Inc. announce re-submission of NDA for Vernakalant (iv)

Published in Medicine and Law Weekly, January 19th, 2007

Cardiome Pharma Corp. (CRME)(COM) and its co-development partner, Astellas Pharma US, Inc., announced Astellas' re-submission of the New Drug Application (NDA) to the United States Food & Drug Administration (FDA) seeking approval to market the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation.

"This re-submission is the culmination of a comprehensive and thorough review process conducted by Astellas Pharma US, Inc., Cardiome and outside consultants," stated Dr. Charles Fisher, executive vice president and chief medical officer of Cardiome. "With the inclusion of an additional 150 patients...

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Source: Medicine and Law Weekly (2007-01-19)

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