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news.Par Pharmaceutical has received approval for its new drug application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the US Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
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Vasostrict is the first and only vasopressin injection, USP, product with an NDA approved by the US FDA and it is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Par Pharmaceutical chief commercial officer Tony Pera said: "Par is very proud to be the first and only company to receive FDA approval for Vasostrict (vasopressin injection, USP).
"Par is committed to providing patients and physicians with pharmaceutical products of uncompromising quality and value."
The company has also started shipping Vasostrict, which is packaged in cartons of 25 multi-dose vials each containing vasopressin 1mL at 20 units/mL.
The drug is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol and its use in patients with impaired cardiac response may worsen cardiac output.