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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Genentech
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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