Posted by Michael Wonder on 24 Jun 2019
Correvio resubmits Brinavess (vernakalant) new drug application to U.S. FDA for the treatment of patients with recent onset atrial fibrillation
24 June 2019 - Correvio Pharma today announced it has resubmitted a new drug application to the U.S. FDA seeking approval for Brinavess (vernakalant hydrochloride, IV), its anti-arrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation.
The application is supported by data from SPECTRUM, a post-approval safety study that was conducted in Europe which evaluated 1,778 unique patients across a total of 2,009 treatment episodes following administration of Brinavess.
