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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  01/04/2010
 
Trade Name:  Xolair
 
Generic 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.
 
Therapeutic Category:  Antiasthmatic
 
Ages Studied:  6-11 years
 
Study #:  2
 
Study Type:  Safety/Tolerability
 
Study Design:  Single-Blind/Placebo
 
No Patients:  334
 
No Centers:  27
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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