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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
Approval Letter
(Text)
Label
(PDF)
Review of Clinical Safety Data
(PDF)
Medical Officer's Efficacy Review
(PDF)
CMC Review
(PDF)
Talkpaper
Last Updated: 8/7/2003
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Updated: September 25, 2003 |
