Vaccines, Blood & Biologics

Resources for You

Proper Name: Influenza Virus Vaccine
Tradename: Fluzone
Manufacturer: Sanofi Pasteur, Inc, License #1725

July 10, 2009 Approval Letter
2009/2010 Season Formulation
May 6, 2009 Approval Letter - Fluzone
Update: New Influenza Vaccine Manufacturing Facility (NIVMF), Building.
FDA Approves New Influenza Vaccine Production Facility
Press Release: May 6, 2009
July 14, 2008 Approval Letter (Revisions to the Package Insert) - Fluzone
Revisions to the Package Insert: To Comply with Physician's Labeling Rule Guidelines.
July 14, 2008 Approval Letter - 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 - Fluzone
New Formulation: 2005-2006 United States formulation.
July 14, 2005 Approval Letter (New Dosage Form) - 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.

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