Lupin Limited, a global leader in pharmaceuticals, has revealed the introduction of Bumetanide Injection USP in the U.S. market after receiving approval from the U.S. Food and Drug Administration (FDA). The injection is offered in Single-Dose Vials containing 1 mg/4 mL (0.25 mg/mL) and Multiple-Dose Vials of 2.5 mg/10 mL (0.25 mg/mL), serving as the generic equivalent of Bumex Injection (0.25 mg/mL) developed by Validus Pharmaceuticals, LLC.

Bumetanide Injection USP is indicated for the management of edema associated with conditions such as congestive heart failure, hepatic disorders, and renal diseases, including nephrotic syndrome. This medication offers a cost-effective substitute for Bumex Injection, catering to the medical needs of patients who require effective treatment for fluid retention.

As stated by Lupin, the reference listed drug (RLD), Bumex, achieved annual sales of roughly USD 20 million in the United States, according to IQVIA data for the 12-month period concluding September 2024.

Lupin’s entry into this sector is anticipated to bolster its injectable segment portfolio, thereby improving access to essential medications for patients throughout the United States.