Par Sterile Products Receives FDA Approval for Up to 12 Months of Storage Out of Refrigeration for Vasostrict® (vasopressin injection, USP)
Chestnut Ridge, NY, May 13, 2015 - Par Sterile Products, a subsidiary of Par Pharmaceutical, Inc., today announced that it has received approval for up to 12 months of storage out of refrigeration for Vasostrict® (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA). 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.
"Twelve-month dating for room-temperature storage of Vasostrict® allows for more effective management of its use on hospital crash carts," said Toni Picone, director, product management for Par Sterile Products. "This extended dating will benefit the health care professionals who administer Vasostrict® and ultimately the patients who rely on this medically important product."
Vasostrict® is packaged in cartons of 25 multi-dose vials each containing vasopressin 1 mL at 20 units/mL and sold as a refrigerated product. Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20°C to 25°C [68°F to 77°F], USP Controlled Room Temperature), anytime within the labeled shelf life. Once removed from refrigeration, unopened vial should be marked to indicate the revised 12 month expiration date. If the manufacturer's original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasostrict® beyond the manufacturer's expiration date stamped on the vial.
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. The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia. These highlights do not include all the information needed to use Vasostrict® safely and effectively. 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.
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