Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee

May 15, 2003

Briefing Information



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Biologics License Application for Xolair™, Genentech, Inc. (HTM) (PDF) (Word)

Omalizumab (Xolair™) Briefing Document on Safety (recombinant humanized monoclonal antibody to IgE) for Treatment of Allergic Asthma, FDA (HTM) (PDF) (Word)

Addendum to Safety Briefing Document (HTM) (PDF) (Word)

Clinical Efficacy Briefing Document, FDA (HTM) (PDF) (Word)

Open Public Hearing

Statement by Dr. Steven Ainbinder, MD (HTM) (PDF) (Word)

Statement by Dr. Stuart Stoloff, MD (HTM) (PDF) (Word)

Statement by Jennifer Merenda, RN (HTM) (PDF) (Word)

Statement by Theodore Vallejos (HTM) (PDF) (Word)

Statement by Joseph Wagner (HTM) (PDF) (Word)

Statement by Carolyn Edwards (PDF)

Statement by the Asthma and Allergy Foundation of America (PDF)

Statement by The Allergy & Asthma Network (PDF)