Lupin gets USFDA tentative approval for new drug; Stock up 1%

Global pharma major Lupin Limited has announced that it 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 Limited. 

This product will be manufactured at Lupin’s Somerset facility in the US, the company said.

Further, 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”, the company stated in a regulatory filing to the exchanges.

On Friday, at around 10:56 AM, shares of Lupin were trading at Rs 1184 per share higher by 1.04% on the BSE.