Product Approval Information
Proper Name: Influenza Virus Vaccine Live, Intranasal
Tradename: FluMist
Manufacturer: MedImmune Vaccines, Inc, License #1652
Package Insert (PDF - 213 KB) - Approved: July 25, 2008
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Date: July 25, 2008
New Formulation: 2008-2009 Unites States formulation
July 25, 2008 Approval Letter
Date: July 3, 2008
Labeling Change: Labeling revisions for the 2008-2009 influenza season
July 3, 2008 Approval Letter
Date: September 19, 2007
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
September 19, 2007 Approval Letter
FDA News - FDA Approves Nasal Influenza Vaccine for Use in Younger Children - 9/19/2007
Consumer Update - Nasal Influenza Vaccine Approved for Younger Children - 9/26/2007
Date: January 5, 2007
New Formulation: Convert from the frozen formulation to a liquid formulation
January 5, 2007 Approval Letter
Date: July 21, 2006
New Formulation: 2006-2007 United States formulation
July 21, 2006 Approval Letter
Date: June 15, 2006
Labeling Change: Labeling revisions for the 2006-2007 influenza season
June 15, 2006 Approval Letter
Date: August 18, 2005
New Formulation: 2005-2006 United States formulation
August 18, 2005 Approval Letter
Date: March 18, 2005
Labeling Change: Changes to the previously approved 2004-2005 US labeling (package insert)
March 18, 2005 Approval Letter
Date: November 2, 2004
New Storage Conditions: Storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox"
November 2, 2004 Approval Letter
Date: June 17, 2003
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
June 17, 2003 Approval Letter
Talkpaper - First Nasal Mist Flu Vaccine Approved - June 17, 2003
Questions and Answers on FluMist (Influenza Virus Vaccine Live, Intranasal)