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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:  01/04/2010
 
Trade Name:  Xolair
 
Generic Name or Proper Name (*):  omalizumab
 
Indications Studied:  Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
 
Label Changes Summary:  * Safety and effectiveness were evaluated in 2 studies in 926 asthma patients 6 to <12 years of age. The risk-benefit assessment does not support use in patients 6 to <12 years considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients e12 years and the modest efficacy of Xolair in the pivotal pediatric study * Studies in patients 0-5 years were not required due to safety concerns of anaphylaxis and malignancy * Information added to Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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