Lupin , a global pharmaceutical leader, 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.
In a press statement on Wednesday, the company informed that the product, available in 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multiple-dose vials, is a generic version of Bumex Injection (0.25 mg/mL) by Validus Pharmaceuticals, LLC.
The injection, manufactured at Lupin’s Nagpur facility in India, is indicated for the treatment of edema associated with congestive heart failure, hepatic disease, and renal disease, including the nephrotic syndrome.
According to IQVIA, Bumetanide Injection USP (RLD Bumex) recorded estimated annual sales of USD 20 million in the U.S. as of July 2024
