Lupin gets USFDA tentative approval for Tolvaptan Tablets

Global pharma company Lupin shares gained on Friday early trade as the company received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg to market a generic equivalent of Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Co., Ltd. 

This product will be manufactured at Lupin’s Nagpur facility in India, the company said in a statement.

According to the filing, Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023).

At around 10:40 AM, shares of Lupin were trading at Rs1159 per share higher by 0.92% on the BSE.