FDA Accepts Cardiome's NDA for Heart Drug
Posted on: Monday, 19 February 2007, 21:00 CST
Cardiome said Monday the U.S. Food and Drug Administration accepted its new drug application for its atrial fibrillation drug, vernakalant.
Cardiome, which is developing the drug with Astellas Pharma, is seeking an indication for the acute conversion of atrial fibrillation.
The NDA, which was submitted last December, is based on a five-year clinical development program.
Vernakalant, which does not yet have a trade name, will be marketed in the United States by Astellas, the U.S. affiliate of a Tokyo-based company of the same name. Cardiome licensed North American commercialization rights to Astellas, but still retains all rights to the intravenous formulations outside of that region.
Source: United Press International
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