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Xolair FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 8, 2020.

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

Apr 12, 2021Approval FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.