FDA does not accept NDA application for Brinavess (vernakalant hydrochloride, IV) to treat atrial fibrillation.- Cardiome Pharma
Cardiome Pharma Corp. announced that it has received a response from the FDA regarding the regulatory path for Brinavess (vernakalant hydrochloride, IV), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its written reply, the FDA advised Cardiome that the data package proposed by Cardiome would not be sufficient to support a resubmission of the Brinavess New Drug Application (NDA).
Brinavess is approved in some 50 countries including the EU and Canada to rapidly restore normal heart rhythm in adult patients (aged 18 years or over) who have recently started having atrial fibrillation.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins