2011: Baxter International acquired Prism Pharmaceuticals for up to $338 mm and launched the Nexterone
NEXTERONE Premixed Injection overcomes the need to admix amiodarone IV, thereby eliminating the potential for medication admixture error," said Dr.
If bradycardia and AV block occur, treat by slowing the infusion rate or discontinuing NEXTERONE.
For more information about NEXTERONE, including full prescribing information, visit www.
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," said Dr.
NEXTERONE represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol.
By formulating with Captisol, Nexterone
allows for the elimination of formulation limiting cosolvents like polysorbate 80 and benzyl alcohol found in the current presentations of amiodarone.
The NEXTERONE premixed IV formulations were recently approved by the FDA in two ready-to-use dosage forms: 150 mg in a 100 mL flexible container for rapid 10-minute loading infusion and 360 mg in a 200 mL flexible container for subsequent loading and maintenance infusions.
Based on our strong hospital relationships and familiarity with the product, Baxter is well-positioned to launch the ready-to-use presentations of NEXTERONE.
The new product is a premixed intravenous (IV) bag formulation of Prism Pharmaceuticals' NEXTERONE Injection, which was the first CyDex licensed proprietary product to achieve NDA approval.
Using Captisol enabled Prism Pharmaceuticals to formulate NEXTERONE Premixed Injection without the cosolvents polysorbate 80 and benzyl alcohol used in the innovator product - the antiarrhythmic agent amiodarone IV originally marketed as Cordarone([R] )Intravenous.