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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2013 Biological License Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.

Tradename/
Proper
 Name              
Indication for Use             
STN
Manufacturer/
License No.
Approval Date

Feiba VH; FEIBA NF
Anti-Inhibitor Coagulant Complex

To update the FEIBA Package Insert (PI) based on the completed clinical study (090701).
 

101447/5576

Baxter Healthcare Corp.
One Baxter Way
Westlake Village, CA  91362

Lic # 0140

12/16/13

Kcentra
Prothrombin Complex Concentrate (Human)

To include an additional indication for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, e.g., warfarin) in adult patients with the need for urgent surgery/invasive procedure.

125421/16

CSL Behring GmbH
1020 First Ave
King of Prussia, PA  19406-0901

Lic #1765

12/13/13

Agriflu
Influenza Vaccine
 
To include a multi-dose vial (MDV) presentation for marketing beginning with the 2014-2015 influenza season at which time relevant labeling will need to be submitted with your strain change supplement.
 
B125297/37Novartis Vaccines and Diagnostics, Inc.
350 Massachusettes Ave, Cambridge MA 
02139
Lic# 1751
10/21/2013
Hizentra
Immune Globulin Subcutaneous (Human) 20% Liquid
 
Treatment of Primary Immunodeficiency (PID)
 
L125350/316
 
CSL Behring AG
1020 First Avenue King of Prussia, PA
Lic# 1766
9/17/2013
FluLaval Quadrivalent
Influenza Virus Vaccine
 
To include use in persons 3 years to 17 years of age for the prevention of influenza disease caused by influenza viruses contained in the vaccine.
 
125163/254
 
ID Biomedical Corporation of Quebec
2323 Technology Park Boulevard
Sainte-Foy Quebec
G!P4R8, Canada

Lic # 1739
8/16/2013
 
FluLaval Quadrivalent
Influenza Virus Vaccine
 
To include a quadrivalent influenza virus vaccine formulation for the prevention of influenza disease in persons 3 years of age or older caused by influenza viruses contained in the vaccine. This quadrivalent formulation will be manufactured at Sainte-Foy, Quebec, Canada facility and will be designated FluLaval® Quadrivalent
 
125163/253
 

ID Biomedical Corporation of Quebec
2323 Technology Park Boulevard
Sainte-Foy Quebec
G!P4R8, Canada

Lic # 1739

08/15/2013
Menveo
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
 
Include safety and effectiveness data to support use in children 2 months through 23 months of age for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.
 
125300/226
 
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge MA 2139, US
Lic # 1751
 
8/1/2013
Reagent Red Blood Cells
 
For the following:
-confirmation of ABO blood grouping in gel techniques.
-detection of unexpected antibodies in gel techniques.
-detection of unexpected antibodies in gel techniques.
-identification of unexpected antibodies in gel techniques.
 
103898/5063
 
Medion Grifols Diagnostics AG CH-3186 Dudingen Switzerland
License 1740
 
7/19/2013
Fluzone Quadrivalent
Influenza Virus Vaccine
 
Include a quadrivalent influenza virus vaccine formulation (Fluzone® Quadrivalent) manufactured at your Swiftwater, PA facility for use in persons 6 months of age and older.
 
103914/5574Sanofi Pasteur Inc.
Discovery Drive
Swiftwater PA
18370-0187
License 1725
6/7/2013
Ixiaro
Japanese Encephalitis Vaccine,
Inactivated, Adsorbed
To extend the age range to include infants, children, and adolescents 2 months to <17 years of age for active immunization for the prevention of disease caused by Japanese
encephalitis virus.
125280/125Intercell AG
Campus Vienna
Biocenter 3
1030 Wien
Austria
License 1780
5/17/2013
Gammaplex
Immune Globulin Intravenous (Human) 
 
For the treatment of chronic immune thrombocytopenic purpura (ITP) 
 
125329/55 Bio Products Laboratory
Dagger Lane
Hertfordshire WE6 3BX United Kingdom
License 1811 
 
3/8/2013
Prevnar 13
Pneumococcal 13-valent
Conjugate Vaccine (Diphtheria
CRM197 Protein)
 
Expanded age
indication for children ages 6 through 17 years of age. (Fulfills PMR #1 under 125324/0)
 
125324/767Wyeth Pharmaceuticals Inc.
401 North Middletown Rd
Pearl River, NY
10965
License 0003
 
1/25/2013
Corifact
Factor XIII Concentrate (Human)
 
Expanded indication to include the peri-operative
management of surgical bleeding in patients with congenital Factor XIII deficiency.
 
125385/30
 
CSL Behring GmbH
1020 First Avenue
King of Prussia, PA
19406-0901
License 1765
 
1/24/2013