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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 #:  1
Study Type:  Efficacy/Safety/Pharmacokinetic/Pharmacodynamic
Study Design:  Single-Blind/Placebo/Population Pharmacokinetic
No Patients:  628
No Centers:  87
No Countries:  7