FDA approves new drug application for NEXTERONE Premixed Injection

Nov 19 2010

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved the supplemental new drug application for NEXTERONE® (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.  NEXTERONE Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.   NEXTERONE Premixed Injection is approved in two ready-to-use dosage forms with strengths of 1.5 mg/mL (150 mg/100 mL) for rapid loading infusion and 1.8 mg/mL (360 mg/200 mL) for subsequent infusion.    

"Until now, amiodarone IV required admixture at time of use. NEXTERONE Premixed Injection overcomes the need to admix amiodarone IV, thereby eliminating the potential for medication admixture error," said Dr. Warren D. Cooper, President and CEO of Prism. "The ready-to-use packaging is designed for the storage of NEXTERONE Premixed Injection at the point of use in automated dispensing cabinets and crash carts and offers a two-year shelf life."

Manufacturer-prepared, premixed ready-to-use products represent a preferred approach, when available, to advance initiatives and professional standards for improving IV drug safety. Organizations that promote, support, and monitor implementation of practices intended to assure quality services in the hospital environment include the Joint Commission, the United States Pharmacopeia (USP) and the American Society of Health System Pharmacists (ASHP).  

NEXTERONE Premixed Injection is manufactured for Prism Pharmaceuticals, Inc. by Baxter Healthcare Corporation using Baxter's proprietary GALAXY container technology.