Granules gets USFDA nod for Dofetilide Capsules, used to treat positive sorts of abnormal heartbeat

Granules gets USFDA nod for Dofetilide Capsules, used to treat positive sorts of abnormal heartbeat

by admin- Monday, October 18th, 2021 03:53:14 PM

Granules India introduced that the US Food & Drug Administration (USFDA) has permitted the Abbreviated New Drug Application (ANDA) filed by way of Granules Pharmaceuticals, Inc. (GPI), a completely owned foreign subsidiary of the Company, for Dofetilide Capsules, one hundred twenty five meg, 250 meg, and 500 meg. It is bioequivalent to the reference indexed drug product (RLD), Tikosyn Capsules, one hundred twenty five meg, 250 mcg, and 500 mcg, of Pfizer Inc. This product would be synthetic on the GPI facility located in Chantilly, Virginia, USA and is anticipated to be released rapidly.

Dofetilide drugs are indicated for the upkeep of everyday sinus rhythm (delay in time to recurrence of atrial fibrillation) in patients with atrial traumatic inflammation/atrial flutter of more than one week period who have been converted to ordinary sinus rhythm. They are also indicated for the conversion of atrial fibrillation and atrial flutter to ordinary sinus rhythm.

Granules now has a complete of forty five ANDA approvals from US FDA (43 Final approvals and 2 tentative approvals).

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