Astellas Files New Drug Submission in Canada


Astellas Pharma Canada has filed a new drug submission (NDS) with the Therapeutic Products Directorate of Health Canada seeking approval to market the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation.

Cardiome Pharma is co-developing vernakalant hydrochloride (vernakalant (iv)) with  Astellas Pharma Canada, an affiliate of Cardiome’s partner, Astellas Pharma U.S.

The NDS filing follows the December 2006 submission of a new drug application for vernakalant hydrochloride with the FDA. A decision from the FDA is expected in October, while Health Canada should make its decision in mid-2008.