Lupin bags USFDA okay Dronedarone Tablets
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-02 06:36 GMT | Update On 2024-03-22 08:26 GMT
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Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated New Drug Application for Dronedarone Tablets USP, 400 mg, to market a generic equivalent of Multaq Tablets, 400 mg of Sanofi-Aventis U.S. LLC.
The product will be manufactured at Lupin’s Goa facility in India.
Dronedarone Tablets USP, 400 mg, are indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
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