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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