Biocon Secures U.S. FDA Approval for Norepinephrine Bitartrate Injection

Biocon Pharma Limited has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) single-dose vial. This critical medication is indicated for raising blood pressure in adult patients experiencing acute hypotension. The approval enhances Biocon's portfolio of complex drug products, as the U.S. market for Norepinephrine Bitartrate Injection has seen sales of approximately $40 million in the past year. This milestone reflects Biocon's commitment to expanding its presence in the global pharmaceutical landscape.

 

Source: Biocon Limited