Gland Pharma gets USFDA’s approval for Norepinephrine Bitartrate

12 Aug 2025 Evaluate

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.

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