FDA gives Lupin approval for bumetanide injection
Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
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]