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
|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
|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|
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