Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic medication, used to reduce excessive daytime sleepiness, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (0.5 g/mL), the Mumbai-based drug maker said in a statement.
The company's product is the generic equivalent of Jazz Pharmaceuticals' Xywav Oral Solution, it added.
Lupin said it will produce the medication at its Somerset facility in the US.
The drug maker is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch, it added.
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As per industry estimates, the net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution stood at USD 958.4 million in the year ending December 2022 and USD 604.3 million in the first six months of 2023.
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