Brinavess FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 11, 2019.

FDA Approved: No
Brand name: Brinavess
Generic name: vernakalant
Dosage form: Intravenous Injection
Previous Name: Kynapid
Company: Correvio Pharma Corp.
Treatment for: Atrial Fibrillation

Brinavess (vernakalant) is an investigational antiarrhythmic drug in development for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).

Development timeline for Brinavess

Date	Article
Dec 24, 2019	Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events
Dec 10, 2019	Correvio Announces Outcome Of FDA Advisory Committee Meeting Reviewing Brinavess For The Treatment Of Recent Onset Atrial Fibrillation
Jul 25, 2019	FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant)
Jun 24, 2019	Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation
Aug 21, 2017	Cardiome Provides U.S. Regulatory Update for Brinavess
Aug 12, 2009	Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
Oct 9, 2008	Cardiome Provides Kynapid Regulatory Update
Aug 11, 2008	Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid
Jan 22, 2008	Cardiome And Astellas Announce Kynapid Regulatory Update
Dec 12, 2007	FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
Aug 30, 2007	Cardiome And Astellas Announce Regulatory Extension
Feb 19, 2007	Cardiome And Astellas Announce Acceptance Of NDA For Review
Dec 18, 2006	Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
May 31, 2006	Cardiome Announces Refusal to File Decision By the FDA
Mar 31, 2006	New Drug Application Submitted For RSD1235

Further information

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