Amphastar has gained the Food and Drug Administration’s tentative nod for vasopressin injection, 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 product is the generic of Par Sterile Products’ Vasostrict (vasopressin injection).
Amphastar's CEO and president, Jack Zhang, said, "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 API and the finished product for Vasopressin in the United States."
Vasostrict has a market value of approximately $856 million for the 12 months ended Sept. 30, 2021, according to IQVIA.