Proper Name: Influenza Vaccine
Manufacturer: Protein Sciences Corporation
- For active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine. Flublok is approved for use in persons 18 years of age and older.
October 7, 2016 Approval Letter - Flublok(PDF - 103KB)
To include a quadrivalent formulation (Flublok Quadrivalent).
July 1, 2016 Approval Letter - Flublok(PDF - 28KB)
To include the 2016-2017 United States formulation and associated labeling revisions.
July 1, 2015 Approval Letter - Flublok(PDF - 23KB)
To include the 2015-2016 United States Formulation.
October 29, 2014 Approval Letter - Flublok
To include use in persons 50 years of age and older
- October 28, 2014 Summary Basis for Regulatory Action - Flublok (PDF - 123KB)
June 27, 2014 Approval Letter - Flublok
To include the 2014-2015 United States formulation
October 22, 2013 Approval Letter - Flublok
To include the 2013-2014 United States formulation.
January 16, 2013 Approval Letter - Flublok Summary Basis for Regulatory Action, January 16, 2013 - Flublok(PDF - 180KB)
Please note the above document was originally posted with incorrect information. The corrected IND submission date and information regarding accelerated approval of this product has been corrected in Section 2. BACKGROUND in the current document.
Approval History, Letters, Review, and Related Documents - Flublok