Proper Name: Influenza Vaccine
Manufacturer: Seqirus, Inc.
For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
August 31, 2016 Approval Letter - Flucelvax(PDF - 31KB)
To include the use of MDCK cell isolated candidate vaccine virus strains obtained from two supporting WHO Collaborating Centers for the manufacture of monovalent bulks.
May 23, 2016 Summary Basis of Regulatory Action - Flucelvax(PDF - 152KB) May 23, 2016 Approval Letter - Flucelvax(PDF - 53KB)
To include persons 4 years to <18 years of age according to the regulations for accelerated approval, 21 CFR 601.40-46.
May 2, 2016 Clinical Review Addendum - FLUCELVAX(PDF - 158KB) Statistical Review (STN: 125408/101) – FLUCELVAX(PDF - 323KB) July 2, 2015 Approval Letter - Flucelvax(PDF - 28KB)
To Include the 2015 - 2016 United States formulation and corresponding labeling.
April 2, 2015 Approval Letter - Flucelvax(PDF - 33KB)
To include changes to the package insert.
June 27, 2014 Appoval Letter - Flucelvax
To include the 2014-2015 United States formulation.
June 20, 2014 Approval Letter - Flucelvax[ARCHIVED]
To revise the package insert by adding generalized skin reactions including prutitus, urticaria or non-specific rash to section 6.2, post marketing experience with Flucelvax.
September 6, 2013 Approval Letter - Flucelvax[ARCHIVED]
To revise the package insert by adding reports of anaphylaxis or angioedema to Section 6.2, Postmarketing Experience with Flucelvax, and making other minor editorial changes, has been date stamped and issued.
July 19, 2013 Approval Letter - Flucelvax[ARCHIVED]
To include the 2013-2014 United States Formulation.
November 20, 2012 Approval Letter- Flucelvax Summary Basis of Regulatory Action, November 20, 2012 - Flucelvax(PDF - 229KB) Approval History, Letters, Reviews, and Related Documents - Flucelvax