Astellas/Cardiome Anticipate Oct. 19 Vernakalant User Fee Date
This article was originally published in PharmAsia News
Executive Summary
Astellas Pharma and Cardiome Pharma anticipate an Oct. 19, 2007, user fee date for vernakalant (RSD1235), an intravenous formulation for acute conversion of atrial fibrillation, based upon a 10-month standard FDA review. Astellas resubmitted the NDA for vernakalant Dec 19