FDA Approval Activities for this Drug
Tikosyn (dofetilide) Capsules, Pfizer NDA 20-931 10/4/99 10/4/99 8/16/01 4/4/02
Tikosyn Indication: (1) Maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial blutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. (2)For the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. | Tikosyn (dofetilide) Capsules, Pfizer Inc., Labeling Revision