Biocon Limited announced on March 24, 2025, that its wholly owned subsidiary, Biocon Pharma Limited, has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) in a single-dose vial.
The drug is indicated for raising blood pressure in adult patients with acute hypotension, marking a significant addition to Biocon’s portfolio of complex injectable products. The approval enhances Biocon Pharma’s growing presence in the U.S. generics market and contributes to its strategy of developing niche and critical care medications.
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