CHESTNUT RIDGE, N.Y., Nov. 12, 2014 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received approval for its New Drug Application (NDA) for Vasostrict™ (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (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.
Important Information About Vasostrict™ (vasopressin injection, USP)
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. For full prescribing information, visit www.parpharm.com
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.