Amphastar Pharma receives tentative approval from US FDA for Vasopressin injection

Amphastar Pharmaceuticals, Inc has received tentative approval from the US Food and Drug Administration (FDA) for Vasopressin injection, USP 20 units/mL, 1mL single-dose vial. Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. The FDA determined that Amphastar’s vasopressin is bioequivalent and therapeutically equivalent to Par Sterile Products LLC’s Vasostrict, the company notified via a statement.

According to IQVIA, the US sales for Par’s Vasopressin injection were approximately $856 million for the 12 months ended 30th September, 2021.

The timing of Amphastar’s commercialisation of its vasopressin product is subject to the confidential terms in the Settlement Agreement between the company and Par and the FDA’s grant of the final approval for the ANDA, the statement added.