Posted by Michael Wonder on 25 Jul 2019
U.S. FDA accepts Correvio's resubmitted new drug application for Brinavess (vernakalant)
25 July 2019 - NDA seeks pproval for Brinavess for the treatment of recent onset atrial fibrillation; PDUFA date set for 24 December 2019.
Correvio Pharma today announced that the U.S. FDA has accepted for review the resubmitted new drug application for Brinavess (vernakalant hydrochloride), an anti-arrhythmic drug for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adult patients.
The FDA assigned a target action date of 24 December 24 2019 under the Prescription Drug User-Fee Act. In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application.
