Global pharma major Lupin Limited (Lupin) today 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, 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 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.
Shares of Lupin Limited was last trading in BSE at Rs. 1171.80 as compared to the previous close of Rs. 1159.20. The total number of shares traded during the day was 170758 in over 1649 trades.
The stock hit an intraday high of Rs. 1192.50 and intraday low of 1160.05. The net turnover during the day was Rs. 200710899.00.