The United States Food & Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a foreign wholly owned subsidiary of Granules India Ltd, for dofetilide capsules , 125 mcg, 250 mcg, and 500 mcg. It is bioequivalent to the Reference Pharmaceutical Product (RLD), Tikosyn * Capsules, 125 mcg, 250 mcg and 500 mcg, from Pfizer Inc. This product is said to be manufactured at the GPI plant located in Chantilly, Virginia, USA and is expected to be to be launched shortly.
Dofetilide capsules are indicated for the maintenance of a normal sinus rhythm (time to atrial fibrillation recurrence) in patients with atrial fibrillation / atrial flutter for more than one week who have been converted to a 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 US FDA ANDA approvals (43 final approvals and 2 interim approvals).
Dofetilide Capsule products recorded sales in the United States of approximately $ 39 million in the past twelve months ending August 2021 according to IQVIA Health.
* Tikosyn is a registered trademark of Pfizer, Inc.
Shares of Granules India Limited were last trading on BSE at Rs. 328.45 from the previous close of Rs. 330.80. The total number of shares traded during the day was 43,904 in over 925 transactions.
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