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Kynapid Approval Status

  • FDA approved: No
  • Brand name: Kynapid
  • Generic name: vernakalant
  • Dosage form: Intravenous Injection
  • Previous name: RSD1235
  • Company: Cardiome Pharma Corp.
  • Treatment for: Atrial Fibrillation

Kynapid (vernakalant) is an investigational antiarrhythmic drug intended for rapid conversion of atrial fibrillation to sinus rhythm.

In August 2008, Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Kynapid was approvable pending additional information. While vernakalant is currently available in many countries, it remains commerically undeveloped in the United States.

Development Status and FDA Approval Process for Kynapid

DateArticle
Aug 12, 2009Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
Oct  9, 2008Cardiome Provides Kynapid Regulatory Update
Aug 11, 2008Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid
Jan 22, 2008Cardiome And Astellas Announce Kynapid Regulatory Update
Dec 12, 2007FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
Aug 30, 2007Cardiome And Astellas Announce Regulatory Extension
Feb 19, 2007Cardiome And Astellas Announce Acceptance Of NDA For Review
Dec 18, 2006Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
May 31, 2006Cardiome Announces Refusal to File Decision By the FDA
Mar 31, 2006New Drug Application Submitted For RSD1235

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