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Xolair FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 21, 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.

Development timeline for Xolair

Feb 25, 2024Antibody Reduces Allergic Reactions to Multiple Foods in NIH Clinical Trial
Feb 16, 2024Approval FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies
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

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