Last Updated on December 31, 2023 by The Health Master
Aurobindo Pharma Ltd announced that its wholly-owned arm, Eugia Pharma Specialties Ltd, has received final approval from the US health regulator for its generic version of Vasopressin injection.
The injection is indicated to increase blood pressure in adults who suffer from sudden relaxation of blood vessels, according to PTI.
The approval granted by the US Food and Drug Administration (USFDA) is for the manufacturing and marketing of vasopressin injection at a strength of 20 units per milliliter of multiple-dose vials, Aurobindo Pharma said in a regulatory filing.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Vasostrict injection, 20 units/ml of Par Sterile Products, LLC (Par), it added.
Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shocks, such as due to post-cardiotomy or sepsis, and who remain hypotensive despite fluids and catecholamines.
The product will be launched immediately, the company said.
The approved product has an estimated market size of around USD 606 million for the 12 months ending June 2022, the company said, citing IQVIA data.
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