July 12, 2010 Approval Letter - FluMist Label Revisions
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
July 12, 2010
Our STN: BL 125020/1324
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 (BLA) for Influenza Vaccine Live, Intranasal, to include a new Patient Package Insert (PPI) and the revised Package Insert (PI) for 2010-2011 United States formulation.
Please note that the carton and container labels for the 2010-2011 United States formulation of FluMist are being reviewed along with your annual strain change supplement under
STN 125020/1436. Please note that the revised PI and new PPI cannot be used until the above mentioned supplement for 2010-2011 Unites States formulation is approved.
Please submit all final printed labeling at the time of use and include implementation information on Forms FDA 356h. Provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics 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