Amphastar Receives FDA Approval for Vasopressin

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Jul 19, 2022

RANCHO CUCAMONGA, CA / ACCESSWIRE / July 19, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Vasopressin injection, USP 20 Units/mL, 1mL Single Dose Vial. In December 2021, the Company had received FDA tentative approval for the ANDA. 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® (Vasopressin Injection, USP).