February 3, 2010 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)
Our STN: BL 125020/1337
Attention: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Kavanaugh:
We have received your January 29, 2010, supplement to your biologics license application for Influenza Vaccine Live, Intranasal (FluMist®), to include changes to the Adverse Reaction reporting information in the Highlights section of the package insert for Influenza A (H1N1) 2009 Monovalent Vaccine, Live formulation, to accommodate the distribution of vaccine outside of United States by the WHO.
This Supplement has been reviewed under STN 125020/1337 and is approved effective this date.
This information will be included in your License Application File.
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling