Granules Pharmaceuticals, Inc gets ANDA approval for Dofetilide Capsules

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Ltd, 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 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.

*Tikosyn is a registered trademark of Pfizer, Inc.

Shares of Granules India Limited was last trading in BSE at Rs. 328.45 as compared to the previous close of Rs. 330.80. The total number of shares traded during the day was 43904 in over 925 trades.

The stock hit an intraday high of Rs. 333.45 and intraday low of 328.00. The net turnover during the day was Rs. 14483802.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 Pharmaceuticals ANDAApproval DofetilideCapsules