Aurobindo Pharma subsidiary Eugia Pharma Specialties has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Vasopressin injection USP, 20 units/mL multiple dose vials.

Bioequivalent and therapeutically equivalent to reference listed drug Vasostrict Injection, 20 units/mL of Par Sterile Products LLC, the approved product’s estimated market size is about $606 million for the 12 months ended June 2022, the drugmaker said, citing IQVIA numbers.

The product is being unveiled immediately, it said. Vasopressin Injection USP is indicated to increase blood pressure in adults with vasodilatory shock (post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

This is the 146th abbreviated new drug application (ANDA), including 10 tentative approvals, received out of Eugia Pharma Speciality Group (EPSG) facilities that manufacture both oral and sterile specialty products, Aurobindo said. The company’s shares closed 1.59% lower at ₹583.85 apiece.

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Printable version | Aug 16, 2022 7:26:53 pm | https://www.thehindu.com/business/aurobindo-pharma-arm-gets-us-fda-nod-for-vasopressin-shot/article65775633.ece