Last Updated on October 17, 2024 by The Health Master
Amphastar Pharmaceuticals, Inc. has received tentative approval from the US Food and Drug Administration (USFDA) for Vasopressin injection, USP 20 units/mL, 1 mL single-dose vial.
Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
The USFDA determined that Amphastar’s vasopressin is bioequivalent and therapeutically equivalent to Par Sterile Products LLC’s Vasostrict, the company said in 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 final approval for the ANDA, the statement added.
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