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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2009 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.


Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated 125251/0 Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235
A-1100 Vienna Austria
License 1646
12/4/2009
Agriflu
Influenza Virus Vaccine
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 125297/0 Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge, MA 02139-4182
License No. 1751
11/27/2009
Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females 10-25 years of age. 125259/0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
10/16/2009
ALBAclone
Anti-A (Murine Monoclonal)
Manufacture of Anti-A (Murine Monoclonal) from the cell line LA2 125301/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
ALBAclone Anti-B
Anti-B (Murine Monoclonal)
Manufacture of Anti-B (Murine Monoclonal) from the cell line LB3 125302/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT
United Kingdom
License 1807
10/16/2009
Anti-A,B (Murine Monoclonal) Manufacture of Anti-A,B (Murine Monoclonal) from the cell lines LA2/LB3/ES15 125303/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-D (Monoclonal) (IgM) Manufacture of Blood Grouping Reagent, Anti-D (Monoclonal) (IgM) from the cell line LDM1 and Anti-D (Monoclonal) (IgM) from the cell line LDM3 125304/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-E (Monoclonal) Manufacture of Anti-E (Monoclonal) from the cell line DEM1 125305/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-c (Monoclonal) Manufacture of Anti-c (Monoclonal) from the cell line H48 125306/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-k (Murine Monoclonal) Manufacture of Anti-k (Murine Monoclonal) from the cell line LKL1 125307/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-M (Murine Monoclonal) Manufacture of Anti-M (Murine Monoclonal) from the cell line LM1 125308/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-N (Murine Monoclonal) Manufacture of Anti-N (Murine Monoclonal) from the cell line LN3 125309/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-Lea (Murine Monoclonal) Manufacture of Anti-Lea (Murine Monoclonal) from the cell line LEA2 125310/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-Leb (Murine Monoclonal) Licensure of Anti-Leb (Murine Monoclonal) from the cell line LEB2 125311/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-Lub (Murine Monoclonal) Licensure of Anti-Lub (Murine Monoclonal) from the cell line LU2 125312/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-D (Monoclonal)(IgM Blend) Licensure of Anti-D (Monoclonal) (IgM Blend) from the cell lines LDM1/ESD1-M 125313/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Anti-D (Monoclonal Blend) Licensure of Anti-D (Monoclonal Blend) from the cell lines LDM3/ESD1 125314/0 Alba Bioscience Limited Ellen's Glen Rd
Edinburgh EH17 7QT 
United Kingdom
License 1807
10/16/2009
Berinert
C1 Esterase Inhibitor (Human)
For the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients 125287/0

CSL Behring GmbH

1020 First Avenue
King of Prussia , PA 19406-0901
License 1765

10/9/2009
ABBOTT PRISM HIV O Plus
Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide
Detect antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 ( anti-HIV-2) in human serum and plasma specimens 125318/0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Rd
Abbott Park, IL 60064
License 0043
9/18/2009
Gammaplex
Immune Globulin Intravenous (Human)
Treatment of patients with primary humoral immunodeficiency (PI) 125329/0 Bio Products Laboratory
Dagger Lane
Elstree
Hertfordshire, United Kingdom  WE6 3BX
9/17/2009
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday). 125347/0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart 
Belgium
License 1617
8/19/2009
Red Blood Cells Shared manufacturing agreement with The Blood Center to freeze and deglycerolize red cells. 125292/0 Medical Center of Louisiana
2021 Perdido St.
New Orleans, LA 70112-1396
License 1800
5/28/2009
Source Plasma New manufacturer of source plasma. 125339/0 Octapharma Plasma, Inc.
736 Park North Blvd.
Clarkston, GA 30021
License 1817
5/28/2009
IXIARO
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
 
For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older 125280/0
 
Intercell AG
Campus Vienna Biocenter 2
1030 Vienna, Austria
License 1790
3/30/2009
ATryn
Antithrombin (Recombinant)
For the prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients. 125284/0 GTC Biotherapeutics, Inc.
175 Crossing Blvd.
Framingham , MA 01702
License 1794
2/6/2009
RiaSTAP
Fibrinogen Concentrate (Human)
For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). 125317/0 CSL Behring GmbH
1020 First Avenue
King of Prussia , PA 19406-0901
License 1765
1/16/2009