Reduces allergic reactions (Type I), including anaphylaxis. BLA 103976, held by Genentech. Omalizumab.
As of Nov 14, 2026, BLA 103976 (Xolair), held by Genentech, was first approved by FDA on Jun 20, 2003, with 20 approved supplements and 0 published complete response letters.
XOLAIR is an anti-IgE antibody 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.
| Feb 16, 2024 | Supplement 5245Efficacy (new indication or use) · Priority review | Approved | |
| Apr 9, 2021 | Supplement 5238Efficacy (new indication or use) · Standard review | Approved | |
| Nov 30, 2020 | Supplement 5235Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2018 | Supplement 5231Efficacy (new indication or use) · Priority review | Approved | |
| Jul 6, 2016 | Supplement 5225Efficacy (new indication or use) · Standard review | Approved | |
| Sep 26, 2014 | Supplement 5161Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2014 | Supplement 5211Efficacy (new indication or use) · Standard review | Approved | |
| Jan 4, 2010 | Supplement 5166Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2003 | Original applicationNew molecular entity · Standard review | Approved |
| Xolair150MG/VIAL · vial | Omalizumab | Rx |
| Xolair75MG/0.5ML · syringe | Omalizumab | Rx |
| Xolair150MG/ML · syringe | Omalizumab | Rx |
| Xolair300MG/2ML · syringe | Omalizumab | Rx |
| Aug 6, 2026 | Supplement 5253Labeling · Standard review | Approved | |
| Feb 16, 2024 | Supplement 5245Efficacy (new indication or use) · Priority review | Approved | |
| Aug 17, 2023 | Supplement 5242Manufacturing | Approved | |
| Mar 17, 2023 | Supplement 5243Labeling · Standard review | Approved | |
| Jul 22, 2021 | Supplement 5239Manufacturing · Standard review | Approved | |
| Apr 9, 2021 | Supplement 5238Efficacy (new indication or use) · Standard review | Approved | |
| Nov 30, 2020 | Supplement 5235Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2019 | Supplement 5234Labeling · Standard review | Approved | |
| Sep 28, 2018 | Supplement 5231Efficacy (new indication or use) · Priority review | Approved | |
| Jul 6, 2016 | Supplement 5225Efficacy (new indication or use) · Standard review | Approved | |
| Dec 3, 2015 | Supplement 5224Labeling · Standard review | Approved | |
| Sep 26, 2014 | Supplement 5161Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2014 | Supplement 5211Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2011 | Supplement 5191Labeling · Standard review | Approved | |
| Dec 21, 2010 | Supplement 5180Labeling · Standard review | Approved | |
| Jul 30, 2010 | Supplement 5165Labeling · Standard review | Approved | None posted |
| Jan 4, 2010 | Supplement 5166Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2009 | Supplement 5154Labeling · Standard review | Approved | None posted |
| Jul 2, 2007 | Supplement 5102Labeling · Standard review | Approved | |
| Apr 7, 2006 | Supplement 5087 | Approved | |
| Jun 20, 2003 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
