Posted by Michael Wonder on 24 Aug 2017
Cardiome provides U.S. regulatory update for Brinavess
21 August 2017 - Cardiome Pharma Corporation today announced that it has received a response from the U.S. FDA regarding the regulatory path for Brinavess (vernakalant hydrochloride), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation.
In its written reply, the FDA advised Cardiome that the data package proposed by Cardiome would not be sufficient to support a resubmission of the Brinavess new drug application.
