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Nexterone Approval History

FDA Approved: Yes (First approved December 24, 2008)
Brand name: Nexterone
Generic name: amiodarone HCl
Dosage form: Injection
Company: Prism Pharmaceuticals
Treatment for: Ventricular Fibrillation, Ventricular Tachycardia

Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Development History and FDA Approval Process for Nexterone

DateArticle
Nov 19, 2010Approval Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection
Jan  5, 2009Approval Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Further information

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