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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:  08/21/2009
 
Trade Name:  Xyzal
 
Generic Name or Proper Name (*):  levocetirizine dihydrochloride
 
Indications Studied:  Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older
 
Label Changes Summary:  * Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older * Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older * Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older * Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics * Patient population altered
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  UCB
 
Pediatric Exclusivity Granted Date:  08/25/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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