Granules India arm gets USFDA nod for Dofetilide capsules
Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Telangana: Granules India has recently announced that the 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 the Company, for Dofetilide Capsules, 125 mcg, 250 mcg, and 500 mcg.
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," the company said in a BSE filing.
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.
Read also: Granules gets Health Canada nod for arthritis drug Acetaminophen ER tablets
In July, Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located in Chantilly, Virginia, USA had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (USFDA) from 21st June 2021 to 25th June 2021.
Read also: Granules India Arm Clears USFDA Audit
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.
