November 2, 2004 Approval Letter - Influenza Virus Vaccine Live, Intranasal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
November 2, 2004
Submission Tracking Number (STN): BL 125020/43
Peter Patriarca, M.D.
MedImmune Vaccines, Inc.
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Patriarca:
We have received your October 20, 2004, Supplement to your Biologics License Application (BLA) for Influenza Virus Vaccine Live, Intranasal (FluMist), to include the storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox."
This acknowledgment recognizes that your submission is in the form of a "Prior Approval Supplement" as described under 21 CFR 601.12 (b)(1). This Supplement has been reviewed under STN 125020/43 and is approved effective this date.
This information will be included in your Biologics License Application file. It is recommended that a copy of this letter be available for review at the time of FDA inspections.
--- signature ---
Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research