Pharma Focus Asia

Amphastar Receives FDA Tentative Approval for Vasopressin

Thursday, December 30, 2021

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® (Vasopressin Injection, USP).

Amphastar's CEO and President, Dr. Jack Zhang, commented: "The FDA's approval of our Vasopressin injection shows the Company's continued commitment and the ability to develop peptide and protein products and the ability to manufacture high-quality injection products for hospital care. The Company will manufacture its Active Pharmaceutical Ingredient (API) and the finished product for Vasopressin in the United States."

According to IQVIA, the U.S. sales for Par's VASOSTRICT® (Vasopressin Injection, USP) 20 Units/mL, 1mL, were approximately $856 million for the 12 months ended September 30, 2021.

The timing of Amphastar's commercialization 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.

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