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# Injectable Cetirizine Approved for Acute Urticaria
- URL: https://www.fdaweb.com/injectable-cetirizine-approved-for-acute-urticaria/
- Published: 2019-10-16T12:00:00.000Z
- Updated: 2026-09-15T01:56:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145268

FDA has approved a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults and children six months of age and older. Approval was based on data from a trial involving 262 patients aged 18 years of age and older who presented to an emergency department or urgent care center with acute urticaria. Patients were treated with either 10 mg of Quzyttir, or 50 mg diphenhydramine injection, according to the company. Quzyttir injection was demonstrated to be non-inferior to diphenhydramine injection. Additionally, the proportion of patients returning to any emergency department or clinic was lower in the Quzyttir treatment group (6%) compared to the diphenhydramine treatment group (14%), the company says. Oral cetirizine was approved in 1995 and is marketed under Johnson & Johnson’s Zyrtec brand.