Xolair

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
BLA103976 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xolair Is An Anti-Ige Antibody Indicated For: Moderate To Severe Persistent Asthma In 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 ( 1.1 ) Chronic Idiopathic Urticaria In Adults And Adolescents 12 Years Of Age And Older Who Remain Symptomatic Despite H1 Antihistamine Treatment ( 1.2 ) Limitations Of Use: Not Indicated For Other Allergic Conditions Or Other Forms Of Urticaria. ( 1.1 , 1.2 ) Not Indicated For Acute Bronchospasm Or Status Asthmaticus. ( 1.1 , 5.3 ) 1.1 Asthma Xolair Is Indicated For Patients 6 Years Of Age And Older With Moderate To Severe Persistent Asthma Who Have A Positive Skin Test Or In Vitro Reactivity To A Perennial Aeroallergen And Whose Symptoms Are Inadequately Controlled With Inhaled Corticosteroids. Xolair Has Been Shown To Decrease The Incidence Of Asthma Exacerbations In These Patients. Limitations Of Use: Xolair Is Not Indicated For The Relief Of Acute Bronchospasm Or Status Asthmaticus. Xolair Is Not Indicated For Treatment Of Other Allergic Conditions. 1.2 Chronic Idiopathic Urticaria (Ciu) Xolair Is Indicated For The Treatment Of Adults And Adolescents 12 Years Of Age And Older With Chronic Idiopathic Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment. Limitation Of Use: Xolair Is Not Indicated For Treatment Of Other Forms Of Urticaria.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omalizumab

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