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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:  07/06/2016
 
Trade Name:  Xolair
 
Generic Name or Proper Name (*):  omalizumab
 
Indications Studied:  Moderate to severe persistent asthma in pediatric patients 6 to 11 years of age
 
Label Changes Summary:  *Safety and efficacy of Xolair for asthma were evaluated in 2 trials in 926 (Xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma. *Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. *Information on dosing, immunogenicity, adverse reactions, clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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