Brinavess Approval Status
FDA Approved: No
Brand name: Brinavess
Generic name: vernakalant
Dosage form: Intravenous Injection
Previous Name: Kynapid
Company: Cardiome Pharma Corp.
Treatment for: Atrial Fibrillation
Brinavess (vernakalant) is an investigational antiarrhythmic drug intended for rapid conversion of atrial fibrillation to sinus rhythm.
Development Status and FDA Approval Process for Brinavess
|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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