Product Approval Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
July 21, 2006
Our Submission Tracking Number (STN): BL 125020/238
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 the 2006-2007 United States formulation.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
Jerry A. Weir, Ph.D.Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research