U.S. License Holder:
Genentech
Date of License:
June-20-2003
Last Update:
Sep-15-2023
FDA-Approved Indications
XOLAIR (omalizumab) 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;
Nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment;
Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.