Vaccines, Blood & Biologics
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FluMist
Proper Name: Influenza Vaccine Live, Intranasal
Tradename: FluMist
Manufacturer: MedImmune, LLC, License #1799
STN: BL 125020
Indications:
- For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
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Supporting Documents
June 20, 2012 Approval Letter-FluMist
To include the 2012-2013 United States formulation.January 27, 2012 Approval Letter - FluMist
To update the package insert to include reorganization of the listing of inactive ingredients.June 30, 2011 Approval Letter - FluMist 2011/2012 Forumation
2011-2012 United States FormulationSummary Basis for Regulatory Action (PDF - 57KB)May 26, 2011 Approval Letter - FluMist
To revise the package insert to include data from clinical trials characterizing vaccine virus shedding in healthy subjects and from small studies of immunocompromised subjects after administration of FluMist.July 22, 2010 Approval Letter - FluMist
2010-2011 United States FormulationJuly 12, 2010 Approval Letter - FluMist Label Revisions
2010-2011 United States FormulationJuly 17, 2009 Approval Letter - FluMist Label Revisions
2009/2010 Season FormulationJuly 17, 2009 Approval Letter - FluMist 2009/2010 Formulation
2009/2010 Season FormulationJuly 25, 2008 Approval Letter - Influenza Virus Vaccine Live, Intranasal
New Formulation: 2008-2009 Unites States formulation.July 3, 2008 Approval Letter - Influenza Virus Vaccine Live, Intranasal
Labeling revisions for the 2008-2009 influenza season.September 19, 2007 Approval Letter - Influenza Virus Vaccine Live, Intranasal
Indication Revision: For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.FDA Approves Nasal Influenza Vaccine for Use in Younger Children
Press Release: September 19, 2007Nasal Influenza Vaccine Approved for Younger Children
Consumer Article: September 2007January 5, 2007 Approval Letter - Influenza Virus Vaccine Live, Intranasal
New Formulation: Convert from the frozen formulation to a liquid formulation.July 21, 2006 Approval Letter - Influenza Virus Vaccine Live, Intranasal
New Formulation: 2006-2007 United States formulation.June 15, 2006 Approval Letter - Influenza Virus Vaccine Live, Intranasal
Labeling Change: Labeling revisions for the 2006-2007 influenza season.August 18, 2005 Approval Letter - Influenza Virus Vaccine Live, Intranasal
New Formulation: 2005-2006 United States formulation.March 18, 2005 Approval Letter - Influenza Virus Vaccine Live, Intranasal
Labeling Change: Changes to the previously approved 2004-2005 US labeling (package insert).November 2, 2004 Approval Letter - Influenza Virus Vaccine Live, Intranasal
New Storage Conditions: Storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox".June 17, 2003 Approval Letter - Influenza Virus Vaccine Live, Intranasal
Indication: For active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.FluMist (Intranasal Influenza Virus Vaccine) Questions and Answers
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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