U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for NEXTERONE® (amiodarone HCl) Injection, which is a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, as announced by Prism Pharmaceuticals.  NEXTERONE® (amiodarone HCl) Injection was 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.

Dr. Warren D. Cooper, President and CEO of Prism said, "Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move NEXTERONE from licensing to FDA clearance in less than three years and ahead of the PDUFA target date.” He added, "We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias."

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