The U.S. Food & Drug Administration (FDA), has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India for Dofetilide capsules, 125 mcg, 250 mcg, and 500 mcg. It is bioequivalent to the reference listed drug product (RLD), Tikosyn capsules, 125 mcg, 250 mcg, and 500 mcg, of Pfizer Inc. This product would be manufactured at the GPI facility located in Chantilly, Virginia, USA and is expected to be launched shortly.

Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. They are also indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.

Granules now has a total of 45 ANDA approvals from the FDA (43 final approvals and 2 tentative approvals).

Dofetilide capsule products had U.S. sales of approximately US $ 39 million for the most recent twelve months ending in August 2021 according to IQVIA Health.