EAST WINDSOR, N.J. — Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Dofetilide Capsules, 0.125 mg, 0.25 mg, and 0.5 mg. Aurobindo’s dofetilide capsules are an AB-rated generic equivalent to the reference listed drug, Pfizer’s Tikosyn.
Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm.
Dofetilide capsules has an estimated market size of $52M for the twelve months ending November 2018 according to IMS.