Gland Pharma Receives USFDA Approval for Vasopressin 5% Dextrose Injection USP (RTU vial)

Gland Pharma Ltd has received approval from the USFDA for its Abbreviated New Drug Application for Vasopressin in 5% Dextrose Injection, 40 Units per 100 mL (0.4 Units per mL) RTU Vials and tentative approval for Vasopressin in 5% Dextrose Injection, 20 Units per 100 mL (0.2 Units per mL) RTU Vials. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL (0.4 Units per mL) and 20 Units per 100 mL (0.2 Units per mL) of PH Health Limited. The product is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. As per IQVIA, the product had US sales of approximately USD 45 million for the twelve months ending June 2025.