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.