Date: 29-Jul-2019

US FDA accepts Correvios resubmitted NDA for Brinavess

Correvio Pharma Corp, a specialty pharmaceutical company focused on commercializing hospital drugs, announced that the US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application.