Product Approval Information - Licensing Action
July 25, 2008
Our Submission Tracking Number (STN): BL 125020/794
MedImmune Vaccines, Inc.
Attention: 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 2008-2009 Unites States formulation.
Please note that the use of updated labeling for marketing your product was approved under STN 125020/716. We will include the information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Jerry P. Weir/
Jerry P. Weir, Ph.D.Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research