Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee

May 15, 2003



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.

Biologic License Application Omalizumab for Treatment of Allergic Asthma, Sponsor: Genentech, Dr. Patrick Swann, PhD, FDA (HTM) (PPT)

Genentech Marketing Application STN 103976 / 0 Omalizumab Recombinant Human Anti-IgE for Treatment of Asthma, Efficacy Review, Dr. Kaiser, FDA (HTM) (PPT)

FDA Review of Clinical Safety Data, Dr. Rieves, FDA (HTM) (PPT)