Quzyttir FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 7, 2020.
FDA Approved: Yes (First approved October 4, 2019)
Brand name: Quzyttir
Generic name: cetirizine hydrochloride
Dosage form: Injection
Company: TerSera Therapeutics LLC
Treatment for: Urticaria
Quzyttir (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
- 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 injection is administered as an intravenous push over a period of 1 to 2 minutes, every 24 hours as needed for acute urticaria.
- In a randomized clinical study of 262 patients with acute urticaria, the effectiveness of Quzyttir 10 mg was demonstrated to be non-inferior to diphenhydramine injection 50 mg, with a lower number of Quzyttir-treated patients (6%) returning for follow-up treatment compared to diphenhydramine-treated patients (14%).
- Common adverse reactions (incidence less than 1%) include dysgeusia (altered taste), headache, paresthesia (tingling of the skin), presyncope (lightheadedness), dyspepsia (indigestion), feeling hot, and hyperhidrosis (excessive sweating).
Development timeline for Quzyttir
Further information
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