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
- 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
| Date | Article |
|---|---|
| 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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