Lupin gets tentative approval for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

13 Oct 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 Xywav Oral Solution, 0.5 g/mL of Jazz Pharmaceuticals Ireland. This product will be manufactured at Lupin’s Somerset facility in the US.

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch. The net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (RLD Xywav) were $958.4 million for the year ending December 2022 and $604.3 million for the first six months of 2023

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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2097.85 -5.45 (-0.26%)
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