Lupin Receives US FDA Nod For Generic Multaq tablets

Worldwide pharma significant Lupin Restricted (Lupin) reported that it has gotten endorsement from the US Food and Medication Organization (FDA) for its Truncated New Medication Application for dronedarone tablets USP, 400 mg, to showcase a conventional likeness Multaq tablets, 400 mg of Sanofi-Aventis US LLC. At Lupin's India facility in Goa, the product will be made.

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 (Multaq) had estimated annual sales of USD 510 million in the US (IQVIA MAT December 2023), as per pharmabiz.

Lupin is a development driven transnational drug organization settled in Mumbai, India. By revenue, it ranks among the world's largest generic pharmaceutical companies. Over 100 markets in the United States, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East are served by the company's biotechnology products, APIs, and branded and generic formulations. Their key center regions incorporate pediatrics, cardiovascular, hostile to infectives, diabetology, asthma and against tuberculosis.

The Lupin story began when Dr. Desh Bandhu Gupta founded the Mumbai-based company to use science to improve healthcare in 1968.