Antiarrhythmic Agent Sotylize Gets FDA Approval
Arbor announced that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol HCl) oral solution for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.
Sotylize is the first oral solution formulation of sotalol available. Prior to this approval, the tablet forms were compounded into a liquid suspension for patients who could not swallow pills. Sotalol, an antiarrhythmic, has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol HCl consists of a racemic mixture of two isomers, both of which have similar Class III antiarrhythmic effects.
Sotylize oral solution will be available as a 5mg/mL strength in 250mL and 480mL bottles. It is expected to launch in the first quarter of 2015.
For more information call (866) 516-4950 or visit ArborPharma.com.