Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials to market a generic equivalent of Bumex® Injection, 0.25 mg/mL of Validus Pharmaceuticals, LLC. The product will be manufactured at Lupin’s Nagpur facility in India.

Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S. (IQVIA MAT July 2024).