FDA OKs Cetirizine Injection (Quzyttir) for Acute Urticaria

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The US Meals and Drug Administration (FDA) has accredited cetirizine hydrochloride for intravenous injection (Quzyttir, JDP Therapeutics) for remedy of acute urticaria in adults and youngsters 6 months of age or older.

Quzyttir can be accessible as 10-mg/mL single-use vials.

Based on OptumRx, the approval was based mostly on outcomes of a part 3 double-blind, randomized, active-controlled scientific trial involving 262 sufferers aged 18 or older with acute urticaria. Sufferers have been randomly assigned to obtain cetirizine or diphenhydramine injection. The first efficacy endpoint was change from baseline in patient-rated pruritus rating assessed 2 hours following remedy.

Outcomes confirmed that cetirizine injection was noninferior to diphenhydramine, based mostly on change from baseline in patient-rated pruritus rating (major final result).

Fewer cetirizine-treated sufferers than diphenhydramine-treated sufferers returned to the emergency division or clinic (6% vs 14%).

The efficacy of cetirizine injection for the remedy of urticaria in kids aged 6 months or older is predicated on extrapolation of the efficacy in adults with acute urticaria and supported by pharmacokinetic information with oral cetirizine hydrochloride. Cetirizine injection isn’t advisable in kids aged youthful than 6 years with impaired renal or hepatic perform.

Therapy-emergent opposed reactions included dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling sizzling, and hyperhidrosis.

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