STN: BL 125254
Proper Name: Influenza Virus Vaccine
Manufacturer: bioCSL Pty. Ltd.
- For active immunization of persons ages 5 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine
August 15, 2014 Summary Basis for Regulatory Action - Afluria(PDF - 161KB) August 15, 2014 Approval Letter - AFLURIA
To update the package insert to include the data to support the use of PharmaJet® Stratis® Needle-Free Injection System, in addition to traditional needle and syringe, for the intramuscular administration of AFLURIA.
July 31, 2014 Approval Letter - AFLURIA
To include the 2014-2015 United States formulation
July 19, 2013 Approval Letter - AFLURIA
To include the 2013-2014 United States formulation.
April 4, 2013 Approval Letter - AFLURIA[ARCHIVED]
To revise the package insert.
July 20, 2012 Approval Letter - Afluria[ARCHIVED]
To include the 2012-2013 United States formulation.
- December 2, 2011 Approval Letter - AFLURIA
The original posted document has been replaced to note a change to the pregnancy category which was not included in the original approval letter.
Summary Basis for Regulatory Action, December 1, 2011 - Afluria(PDF - 160KB) August 30, 2010 Clarification Letter - Afluria[ARCHIVED]
This letter is to clarify your pediatric study fulfillment requirements.
July 30, 2010 Approval Letter, Afluria[ARCHIVED]
2010-2011 United States formulation
July 15, 2011 Approval Letter- AFLURIA 2011/2012 Formulation[ARCHIVED]
2011 -2012 United States Formulation
November 10, 2009 Approval Letter - Afluria/Influenza A (H1N1) 2009 Monovalent[ARCHIVED]
Active immunization against influenza for individuals 6 months through 17 of age
July 10, 2009 Approval Letter - Afluria[ARCHIVED] 2009/2010 Season Formulation July 30, 2008 Approval Letter - Afluria[ARCHIVED]
2008-2009 United States formulation.
September 28, 2007 - Afluria
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
Additional Influenza Vaccine Approved for Upcoming Influenza Season[ARCHIVED]
Press Release: September 29, 2007
Approval History, Letters, Reviews, and Related Documents - AFLURIA[ARCHIVED]
Dear Health Care Professional Letter - AFLURIA
FDA Online Label Repository
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FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children[ARCHIVED]
Press Release: November 12, 2009