Lupin gets tentative nod from USFDA for tolvaptan tablets used to treat low sodium levels in blood

Drug firm Lupin Ltd said it secured tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) concerning tolvaptan tablets.
These tablets are available in various strengths, including 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, and are intended to serve as a generic equivalent to Jynarque tablets, a product by Otsuka Pharmaceutical Co Ltd.
Tolvaptan is a medication employed in the treatment of hyponatremia, a medical condition characterised by abnormally low levels of sodium in the bloodstream. Hyponatremia can lead to various health complications, including neurological issues, muscle cramps, and even life-threatening conditions.
The manufacturing of these generic tolvaptan tablets will take place at Lupin’s state-of-the-art facility located in Nagpur, India, according to a stock exchange filing.
Tolvaptan tablets, known as the Reference Listed Drug (RLD) Jynarque, are used in the treatment of specific medical conditions. This drug category has witnessed substantial demand in the US, with estimated annual sales reaching a substantial $287 million, according to data from IQVIA MAT in August 2023.
Source: Cnbctv18