Vaccines, Blood & Biologics
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Fluzone, Fluzone High-Dose and Fluzone Intradermal
STN: BL 103914
Proper Name: Influenza Virus Vaccine
Tradename: Fluzone, Fluzone High-Dose and Fluzone Intradermal
Manufacturer: Sanofi Pasteur, Inc, License #1725
Indication:
- Fluzone is indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
- Fluzone High-Dose is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 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
July 2, 2012 Approval Letter - Fluzone
To include the 2012 - 2013 United States formulationMay 15, 2012 Approval Letter-Fluzone, Fluzone High-Dose and Fluzone Intradermal
To include separate United States prescription information’s (USPI) for Fluzone®, Fluzone High-Dose® and Fluzone Intradermal® formulations, for use in final packaged product beginning in the 2012-2013 season.April 10, 2012 Approval Letter - Fluzone
To include the additional syringe label design for Fluzone 0.25mL, Fluzone 0.5mL and Fluzone High-Dose syringe presentations with a detachable portion for patient records.June 27, 2011 Approval Letter (103914/5440)- Fluzone
To revise labeling to update Section 6.2 Post-Marketing Experience of the prescribing information for Fluzone High-Dose and to update the Octylphenol Ethoxylate (Triton X-100) quantity per dose in Section 11.June 27, 2011 Approval Letter (103914/5449) - Fluzone
To include the 2011 - 2012 United States formulation.May 9, 2011 Summary Basis for Regulatory Action - Fluzone Intradermal (PDF - 147KB)May 9, 2011 Approval Letter - Fluzone Intradermal
To include a formulation for intradermal administration.February 17, 2011 Approval Letter - Fluzone/Fluzone High-Dose
Approved request to supplement biologics license application to include a Patient Package Insert.July 23, 2010 Approval Letter - Fluzone/Fluzone High-Dose
2010-2011 United States FormulationDecember 23, 2009 Approval Letter - Fluzone High-Dose
New High-Dose Formulation.Summary Basis for Regulatory Action - Fluzone High-Dose (PDF - 70KB)
December 23, 2009July 10, 2009 Approval Letter - Fluzone
2009/2010 Season FormulationMay 6, 2009 Approval Letter - Fluzone
Update: New Influenza Vaccine Manufacturing Facility (NIVMF), Building.July 14, 2008 Approval Letter (1) - Fluzone
Revisions to the Package Insert: To Comply with Physician's Labeling Rule Guidelines.July 14, 2008 Approval Letter (2) - Fluzone
New Formulation: 2008-2009 United States formulation.July 13, 2007 Approval Letter - Fluzone
New Formulation: 2007-2008 United States formulation.July 10, 2006 Approval Letter - Fluzone
New Formulation: 2006-2007 United States formulation.July 14, 2005 Approval Letter (1) - Fluzone
New Formulation: 2005-2006 United States formulation.July 14, 2005 Approval Letter (2) - Fluzone
New Dosage Form: Preservative free single dose presentation in a unit dose vial.December 23, 2004 Approval Letter - Fluzone
New Dosage Form: Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes.September 4, 2002 Approval Letter - Fluzone
New Formulation: Preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children.
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Related Information
Fluzone Vaccine Safety
FDA and CDC Update on Fluzone Influenza Vaccine and VAERS Reports of Febrile Seizures in ChildrenFDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Press Release: December 23, 2009 (Fluzone High-Dose)FDA Approves New Influenza Vaccine Production Facility
Press Release: May 6, 2009 (Fluzone)
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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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