Omalizumab (marketed as Xolair) Information
Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, using the contact information at the bottom of this page.
Healthcare Professional Information
FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)[ARCHIVED]
- Information for Healthcare Professionals: Omalizumab (marketed as Xolair) [ARCHIVED]
FDA Alert (2/2007, updated 7/2007)
- Xolair Regulatory History and Labeling from Drugs@FDA
Xolair Medication Guide(PDF - 84KB)
FDA Proposes to Strengthen Label Warning for Xolair[ARCHIVED]
FDA news release (2/21/2007)
- Historical - Information for Healthcare Professionals: Omalizumab (marketed as Xolair) (2/2007)