Lupin bags USFDA okay Dronedarone Tablets

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.

Dronedarone Tablets (RLD Multaq) had estimated annual sales of USD 510 million in the U.S. (IQVIA MAT December 2023).

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Medical Dialogues team had earlier reported that Lupin had received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc.