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news.Prism Pharmaceuticals has got the US Food & Drug Administration (FDA) approval for its supplemental new drug application for Nexterone (amiodarone HCl) Premixed injection, a premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.
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Prism Pharma said that the 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 1.5mg/ml (150mg/100ml) for rapid loading infusion and 1.8mg/ml (360mg/200 ml) for subsequent infusion.
CEO of Prism Pharma president and CEO said that 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, Warren Cooper.
"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."