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Xolair FDA Approval History

FDA Approved: Yes (First approved June 20, 2003)
Brand name: Xolair
Generic name: omalizumab
Dosage form: Subcutaneous Injection
Company: Genentech, Inc.
Treatment for: Asthma, Maintenance, Urticaria, Nasal Polyps

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for:
  • moderate to severe persistent asthma in patients 6 years of age and older
  • chronic idiopathic urticaria in adults and adolescents 12 years of age and older
  • nasal polyps in adult patients 18 years of age and older.

Development Timeline for Xolair

Dec  1, 2020Approval  Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps
Sep 28, 2018Approval  FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
Jul  7, 2016Approval  FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children
Mar 21, 2014Approval  FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria
Jun 20, 2003Approval  FDA Approves Xolair (omalizumab) for Moderate-to-Severe Asthma

Further information

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