Gland Pharma Receives USFDA Approval for Norepinephrine Bitartrate in 5% Dextrose Injection Bags

Gland Pharma Limited has received approval from the USFDA for Norepinephrine Bitartrate in 5% Dextrose Injection, 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) Single-Dose Bags. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE of Baxter Healthcare Corp. This Product is indicated to raise blood pressure in adult patients with severe, acute hypotension. Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of approximately USD 55 million for the twelve months ending June 2025.