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).
Read also: Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder
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.
Read also: Lupin bags tentative USFDA approval for Rivaroxaban Tablets
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes 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. Lupin has 15 manufacturing sites, 7 research centers.
