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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:  03/21/2014
 
Trade Name:  Xolair
 
Generic Name or Proper Name (*):  omalizumab
 
Indications Studied:  Chronic Idiopathic Urticaria (CIU)
 
Label Changes Summary:  Approved for the treatment of CIU in adults and pediatric patients 12 years and older who remain symptomatic despite H1 antihistamine treatment Clinical studies with Xolair have not been conducted in CIU patients less than 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients 12 years and older, the use of Xolair in patients less than 12 years is not recommended Dosing in CIU is not based on serum IgE level or body weight Adverse reactions in adolescents and adults were similar and include miscellaneous infections, arthralgias, headache, nausea, and cough Information on adverse reactions, dosing, and clinical trials in adults and pediatric patients 12 years and older
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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