Product Approval Information - Licensing Action
July 3, 2008
Our Submission Tracking Number (STN): BL 125020/716
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 2008-2009 influenza season.
Please note that the use of this updated labeling for marketing your product is subject to approval of your supplement STN 125020/-------------------------------------------. We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Loris McVittie/
Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Final Draft Labeling