New drugs/drug news.

摘要

The FDA has approved the supplemental New Drug Application (sNDA) for amiodarone HC1 (Nexterone Pre-mixed Injection, Prism Pharma). This is the first premixed intravenous (IV) bag formulation of amiodarone IV, an anti-arrhythmic agent. Nexterone is indicated for the initiation and prophylaxis of recurring and refractory ventricular fibrillation and hemodynamically unstable ventricular tachycardia. The product is sold in two ready-to-use dosage forms as 1.5 mg/mL (150 mg/100 mL) for rapid loading infusions and as 1.8 mg/mL (360 mg/200 mL) for subsequent infusions.Before this approval, the drug had to be mixed at the time of use. The newly formulated product helps to eliminate the potential for errors. It can be stored at the point of use in automated dispensing cabinets and crash carts, and it has a two-year shelf life.