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
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