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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:  09/28/2018
 
Trade Name:  Xolair
 
Generic Name or Proper Name (*):  omalizumab
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *New 75 mg and 150 mg liquid prefilled syringes were approved to treat patients 6 years and older with moderate to severe asthma and to treat patients 12 years and older with chronic idiopathic urticaria. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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