Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL.
According to the press statement, tentative approval is granted to market a generic equivalent of Xywav Oral Solution, 0.5 g/mL of Jazz Pharmaceuticals Ireland Limited.
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 company stated.
The net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (RLD Xywav) were USD 958.4 million for the year ending December 2022 and USD 604.3 million for the first six months of 2023.
