Xolair FDA Approval History
Last updated by Judith Stewart, BPharm on July 15, 2024.
FDA Approved: Yes (First approved June 20, 2003)
Brand name: Xolair
Generic name: omalizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria
Xolair (omalizumab) is an anti-IgE monoclonal antibody for use in the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
- Xolair is indicated for:
- Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
- Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment.
- IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance.
- Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment. - Xolair is administered by subcutaneous injection every 2 or 4 weeks (every 4 weeks for chronic spontaneous urticaria).
Development timeline for Xolair
| Date | Article |
|---|---|
| Feb 25, 2024 | Antibody Reduces Allergic Reactions to Multiple Foods in NIH Clinical Trial |
| Feb 16, 2024 | Approval FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies |
| Apr 12, 2021 | Approval FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications |
| Dec 1, 2020 | Approval Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps |
| Sep 28, 2018 | Approval FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation |
| Jul 7, 2016 | Approval FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children |
| Mar 21, 2014 | Approval FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria |
| Jun 20, 2003 | Approval FDA Approves Xolair (omalizumab) for Moderate-to-Severe Asthma |
Further information
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