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fda approved

FDA gives Lupin approval for bumetanide injection

Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, hepatic disease and renal disease.
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Lupin has received approval from the Food and Drug Administration for bumetanide injection, 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 product is a generic of Validus Pharmaceuticals’ Bumex. 

It will be manufactured at Lupin’s Nagpur facility in India.

[Read more: Lupin receives FDA OK for generic Banzel]

Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including the nephrotic syndrome.

Bumetanide injection had a market value of roughly $20 million, per IQVIA July 2024 data.

[Read more: Lupin rolls out generic Doxil]

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