Lupin Receives FDA Approval for Generic Bumetanide Injection
Key Insights
Lupin has secured FDA approval for its bumetanide injection, available in single and multiple-dose vials, offering a generic alternative to Validus Pharmaceuticals (search)' Bumex.
The bumetanide injection is indicated for treating edema (search) linked to congestive heart failure (search), hepatic, and renal diseases, including nephrotic syndrome (search).
Manufactured at Lupin's Nagpur facility in India, the generic bumetanide injection addresses a market valued at approximately $20 million, according to IQVIA data from July 2024.
Lupin has gained FDA approval for its bumetanide injection, a generic version of Validus Pharmaceuticals (search)’ Bumex, indicated for treating edema (search) associated with congestive heart failure (search), hepatic, and renal diseases, including nephrotic syndrome (search). 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 (search) management.