On 19 November 2024, Lupin announced the launch of Bumetanide Injection USP in the United States following approval from the United States Food and Drug Administration (FDA). The product is available in two formulations: 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multiple-dose vials.
Bumetanide Injection USP is a generic equivalent of Bumex Injection (0.25 mg/mL) by Validus Pharmaceuticals, LLC. It is indicated for the treatment of edema associated with conditions such as congestive heart failure, hepatic disease, renal disease, and nephrotic syndrome.
According to IQVIA MAT September 2024 data, Bumetanide Injection USP (RLD Bumex) recorded an estimated annual sale of USD 20 million in the United States.