Drugs
Omalizumab (marketed as Xolair) Information
FDA ALERT [2/2007, updated 7/2007]: This Alert highlights important revisions to the full prescribing information for Xolair. The updated full prescribing information for Xolair (July 2007) includes a new Boxed WARNING, updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS--Postmarketing Spontaneous Reports. A New Medication Guide [PDF] about the risk of anaphylaxis following administration of Xolair is to be distributed with each dose of Xolair. These revisions address the risk of anaphylaxis following treatment with Xolair. The implications of this new labeling for healthcare professionals who administer Xolair are summarized below. Xolair is approved to treat adults and adolescents (12 years of age and above) 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.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Healthcare Professional Information
- Information for Healthcare Professionals: Omalizumab (marketed as Xolair)
FDA ALERT [2/2007, updated 7/2007] - Omalizumab (marketed as Xolair) - Medication Guide
Medication Guide - Xolair (omalizumab) Prescribing Information July 2007
Other Information
- Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)
(7/16/2009) - FDA Proposes to Strengthen Label Warning for Xolair
(2/21/2007) - Omalizumab (marketed as Xolair) - Regulatory History of Omalizumab from Drugs@FDA
Regulatory History of Omalizumab - Omalizumab (marketed as Xolair) - Historical Information
Contact Us
Report a Serious Problem
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787