Granules Pharma gets USFDA approval for Dofetilide Capsules

This product would be manufactured at the GPI facility located in Chantilly, Virginia, USA, and is expected to be launched shortly.

Oct 18, 2021 03:10 IST India Infoline News Service

Granules India
US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India Limited, for Dofetilide Capsules, 125 meg, 250 meg, and 500 meg.

It is bioequivalent to the reference listed drug product (RLD), Tikosyn Capsules, 125 meg, 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 US FDA (43 Final approvals and 2 tentative approvals).

Dofetilide Capsule products had U.S. sales of approximately $39 million for the most recent twelve months ending in August 2021 according to IQVIA Health,” the pharma company said in a filing on Monday.

Towards close of trade on Monday, Granules India Ltd was trading at Rs325.50 per piece down by Rs2.95 or 0.9% from its previous closing of Rs328.45 per piece on the BSE.

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