Category: Approval/Launch Region: North America · United States Company: Amphastar Pharmaceuticals Inc

Amphastar Receives FDA Tentative Approval for Vasopressin

Amphastar Receives FDA Tentative Approval for Vasopressin
Amphastar Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration ("FDA") has tentatively approved the Company's Abbreviated New Drug Application ("ANDA") 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

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