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 |
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 |
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