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
March 24, 2016 Approval Letter - AFLURIA(PDF - 28KB)
To include non-seasonal updates to the package insert (PI) for the 2016/2017 season and update the post-marketing adverse event terms and include information relating to the Afluria pregnancy exposure and surveillance study in the PI.
July 1, 2015 Approval Letter - AFLURIA(PDF - 28KB)
To include the 2015-2016 United States formulation.
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[ARCHIVED]
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children[ARCHIVED]
Press Release: November 12, 2009