Astellas resubmits vernakalant IV NDA
US drugmaker Cardiome Pharma and its co-development partner, the US unit of Japan's Astellas have resubmitted the New Drug Application to the Food & Drug Administration seeking approval to market the intravenous formulation of vernakalant HCl, an investigational new drug for the acute conversion of atrial fibrillation.
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize IV vernakalant in North America. The companies have co-developed the drug to NDA stage, with Astellas responsible for 75% of development costs. Cardiome retains all rights to the IV formulation outside Canada, the USA and Mexico.
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