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June 15, 2006 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
June 15, 2006
Our Submission Tracking Number (STN): BL 125020/201
MedImmune Vaccines, Inc.
Attn: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Kavanaugh:
We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine Live, Intranasal (FluMist), to include labeling revisions for the 2006-2007 influenza season.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Sincerely yours,
Karen L. Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research