Correvio commercializes brands for acute care. The anti-infective portfolio includes: Xydalba™ (dalbavancin), for the treatment ABSSSI; Zevtera® (ceftobiprole), for the treatment of CAP& HAP. The UK portfolio also includes cardiovascular products: Brinavess® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm, and Aggrastat® (tirofiban hydrochloride)
Based on productive pre-NDA discussions with the U.S. Food and Drug Administration (FDA), Correvio plans to resubmit the Brinavess® (vernakalant hydrochloride, IV) New Drug Application (NDA) during the second quarter of 2019. Brinavess® is Correvio’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). The FDA agreed that no additional studies would be required for the resubmission of the NDA.
Correvio Pharma Corp. (NASDAQ: CORV) today reported preliminary data from SPECTRUM, a post-authorization safety study evaluating Brinavess (vernakalant hydrochloride, IV), its antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), conducted in the European Union (EU).