A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
Phase of Trial: Phase IV
Latest Information Update: 11 Jun 2018
At a glance
- Drugs Vernakalant (Primary)
- Indications Atrial fibrillation
- Focus Adverse reactions
- Acronyms SPECTRUM
- Sponsors Cardiome Pharma
- 11 Jun 2018 According to the Correvio Pharma media release, FDA informed company that it would be permissible to resubmit the BRINAVESS New Drug Application (NDA) and company expects to schedule a Pre-NDA meeting with the Division of Cardiovascular and Renal Products to discuss the content and format of a potential resubmission of the NDA in the fourth quarter of 2018.
- 09 May 2018 Status changed to completed.
- 17 Apr 2018 According to a Cardiome Pharma media release, full clinical study report (CSR) will be available during third quarter 2018 and Cardiome plans to publish these data.