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U.S. Department of Health and Human Services


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Omalizumab Product Approval Information - Licensing Action

Proper name: Omalizumab
Tradename: Xolair
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: For adults and adolescents (12 years of age and above) with 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
Approval Date: 6/20/2003
Type of submission: Biologics license application


Label (PDF)

Review of Clinical Safety Data (PDF)

Medical Officer's Efficacy Review (PDF)

CMC Review (PDF)