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FDA Approves Quzyttir

FDA Approves Quzyttir (cetirizine) Injection for the Treatment of Acute Urticaria

October 11, 2019 - The U.S. Food and Drug Administration (FDA) has approved Quzyttir (cetirizine hydrochloride) injection for the treatment of acute urticaria in adults and children 6 months of age and older. Quzyttir will be available as 10-mg/mL single-use vials for intravenous use.

The safety and efficacy of Quzyttir was demonstrated in a randomized, active-controlled, double-blind, single dose, multicenter, parallel group trial of 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. The primary efficacy endpoint was the change from baseline in patient-rated pruritus score assessed 2 hrs post treatment.

Quzyttir injection was demonstrated to be non-inferior to the effectiveness of 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%), and the time spent in the treatment center was shorter.

The adverse reactions with Quzyttir occurred at an incidence of less than 1% and include: dyspepsia, feeling hot, dysgeusia, headache, paresthesia, presyncope, and hyperhidrosis.

Quzyttir is the first intravenous (IV) formulation of the histamine-1 (H1) receptor antagonist cetirizine. The first oral formulation of cetirizine was approved under the brand name Zyrtec in 1995.

Quzyttir will be distributed by TerSera Therapeutics LLC.

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