 "Aurobindo Pharma")
Aurobindo Pharma Ltd on Tuesday said 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.
The approval granted by the US Food and Drug Administration (USFDA) is for manufacturing and marketing of vasopressin injection of strength 20 units/ml 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 remain hypotensive despite fluids and catecholamines.
The product is being 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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