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Lupin Receives FDA Approval for Generic Bumetanide Injection

• Lupin has secured FDA approval for its bumetanide injection, available in single and multiple-dose vials, offering a generic alternative to Validus Pharmaceuticals' Bumex. • The bumetanide injection is indicated for treating edema linked to congestive heart failure, hepatic, and renal diseases, including nephrotic syndrome. • 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’ 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.
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Reference News

[1]
FDA gives Lupin approval for bumetanide injection | Drug Store News
drugstorenews.com · Sep 24, 2024

Lupin received FDA approval for bumetanide injection, 1 mg/4 ml and 2.5 mg/10 ml vials, a generic of Validus Pharmaceuti...

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