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
|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|
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