Advisory Committee Questions

1. DISCUSSION: Please discuss whether the safety profile of vernakalant for rapid conversion of recent onset atrial fibrillation has been adequately characterized.

2. DISCUSSION: Please discuss whether the efficacy and safety profiles of alternative approaches to cardioversion are relevant to assessment of vernakalant’s benefit-risk assessment.

3. VOTE: Do you recommend approval of vernakalant for the rapid conversion of recent onset atrial fibrillation?

4. DISCUSSION: If vernakalant was approved, what restrictions would you place on patients or on the conditions of use?

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

More from US FDA Performance Tracker

More from Regulatory Trackers