Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed through its partner 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. The company 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 around $55 million for the twelve months ending June 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
