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Latest News : Lupin received approval to market a generic equivalent of Multaq Tablets- Dronedarone Tablets US
Lupin received approval from the U.S. FDA for its ANDA for Dronedarone Tablets USP to market a generic equivalent of Multaq Tablets of Sanofi-Aventis U.S. LLC.
Global pharma major Lupin Limited (Lupin) 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).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
