DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
March 18, 2005
Submission Tracking Number (STN): BL 125020 / 44
Peter Patriarca, MD
MedImmune Vaccines, Inc.
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Patriarca:
The Supplement to your Biologics License Application for the Influenza Virus Vaccine Live, Intranasal (FluMist), to include changes to the previously approved 2004-2005 United States labeling (package insert), has been approved. This information will be included in your License Application file.
Please submit four copies of final printed labeling at the time of use with completed implementation information.
--- signature ---
Karen L. Goldenthal, MD
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachments: Final Draft Package Insert Labeling