Lupin Stock rises: The U.S. Food and Drug Administration has given the pharmaceutical company Lupin preliminary clearance for its abbreviated new drug application (ANDA) for Tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
The drug, a generic version of the Jynarque 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets from Otsuka Pharmaceutical Co., is intended to prevent the rapid deterioration in kidney function in individuals who are at risk for autosomal dominant polycystic kidney disease (ADPKD). The product will be produced by Lupin at its Nagpur facility.
Lupin Stock rises
According to data from IQVIA MAT for August 2023, tolvaptan tablets (RLD Jynarque) had expected annual sales of $287 million in the U.S.
Lupin Share Price: A day after the company announced that it had received provisional approval from the US FDA for Tolvaptan tablets to market a generic version of Jynarque® tablets, shares of the major international pharmaceutical company Lupin are trading higher by 1.26 percent, or Rs 14.50, at Rs 1,162.95, on the BSE.
The stock hit a day’s high of Rs 1165.30 on Friday after closing Thursday’s trading session at Rs 1,148.45 and starting at Rs 1,163.95 on Friday.
We are happy to share this press release about the tentative U.S. FDA approval for the company’s abbreviated new drug application for Tolvaptan tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg to market a generic version of Jynarque® Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Co., Ltd.
According to Lupin, the product would be produced at its Nagpur facility.
According to IQVIA MAT’s August 2023 report, Tolvaptan Tablets (RLD Jynarque®) had expected annual sales of USD 287 million in the U.S.