Lupin Gets FDA Nod for Xywav Generic, Eyes Market Entry

13 Oct 2023 , 03:23 PM

Lupin Limited receives tentative approval from the US FDA for a generic version of Xywav oral solution. The approved product contains calcium, magnesium, potassium, and sodium oxybates in a 0.5 g/mL solution.

Manufacturing will take place at Lupin’s Somerset facility in the US. Lupin holds exclusive first-to-file status and may qualify for a 180-day exclusivity period upon product launch.

Xywav’s net product sales were USD 958.4 million for the year ending December 2022 and USD 604.3 million for the first half of 2023. Lupin is an innovative pharmaceutical company based in Mumbai, India, with a global presence in branded and generic formulations, biotechnology products, and APIs across various markets.

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