Global pharma major Lupin Limited on Wednesday 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 Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
According to a press statement, this approval is granted to market the 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.
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the United States, as per IQVIA MAT August 2023.
