Prism Pharmaceuticals, Inc. announced today that the 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).