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
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.