Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-