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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  10/04/2019
 
Trade Name:  Quzyttir
 
Generic Name or Proper Name (*):  cetirizine hydrochloride
 
Indications Studied:  Treatment of acute urticaria in adults and children 6 months of age and older
 
Label Changes Summary:  *Safety and efficacy have been established in patients 6 months to 17 years of age. *Efficacy for the treatment of acute urticaria down to 6 months is based on extrapolation of the efficacy of Quzyttir in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride in patients 6 months to 17 years of age. *Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients 6 months to 17 years is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses. *Safety in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older. *Quzyttir demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults. *Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years with impaired renal or hepatic function, use in this impaired patient population is not recommended. *Safety and efficacy in patients less than 6 months of age has not been established. *Information on PK parameters and clinical trials. *New dosage form.
 
PREA(P):  P
 
Sponsor:  JDP Therapeutics Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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