Lupin has gained FDA approval for its bumetanide injection, a generic version of Validus Pharmaceuticals’ Bumex, indicated for treating edema associated with congestive heart failure, hepatic, and renal diseases, including nephrotic syndrome. The approval encompasses 1 mg/4 ml (0.25 mg/ml) single-dose vials and 2.5 mg/10 ml (0.25 mg/ml) multiple-dose vials.
The bumetanide injection will be manufactured at Lupin’s facility in Nagpur, India. According to IQVIA data from July 2024, the market value for bumetanide injection is approximately $20 million. This generic alternative aims to provide a cost-effective option for patients requiring bumetanide for edema management.
