Par Pharmaceutical Companies has received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the US Food and Drug Administration (US FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Par’s Vasostrict is the first and only vasopressin injection, USP, product with an NDA approved by the FDA. Vasostrict is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.

“Par is very proud to be the first and only company to receive FDA approval for Vasostrict (vasopressin injection, USP),” said Tony Pera, chief commercial officer of Par Pharmaceutical. “Par is committed to providing patients and physicians with pharmaceutical products of uncompromising quality and value.”

Par has begun shipping Vasostrict, which is packaged in cartons of 25 multi-dose vials each containing vasopressin 1 mL at 20 units/mL.

Vasostrict is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. Use in patients with impaired cardiac response may worsen cardiac output.