Lupin gets US FDA nod for Bumetanide Injection, USP

Lupin announced that it has received approval from the United States Food and Drug Administration (US 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. 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 $ 20 million in the US (IQVIA MAT July 2024).