Lupin Secures USFDA Marketing Approval For New Generic Solution

India Pharma Outlook Team | Friday, 13 October 2023

 India Pharma Outlook Team

Lupin Limited (Lupin) has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for calcium, magnesium, potassium, and sodium oxybates oral solution , 0.5 g/mL, to market a generic equivalent of Jazz Pharmaceuticals Ireland Limited's Xywav oral solution, 0.5 g/mL. Lupin's Somerset factory in the United States will manufacture this product.

Lupin is the first-to-file company and may be eligible for a 180-day exclusivity period at product launch. Calcium,magnesium,potassium,and sodium oxybates oral solution (Xywav) net product sales were USD 958.4 million for the fiscal year ending December 2022 and USD 604.3 million for the first six months of 2023. Lupin is a worldwide pharmaceutical firm based in Mumbai, India that focuses on innovation. The firm develops and commercializes a diverse variety of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

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