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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2007 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
Source Plasma Manufacture of WB, RBC, Autologous WB, Autologous RBC, FFP. 125263/0 Community Blood Center of the Carolinas
4447 South Boulevard
Charlotte, NC 28209
License No. 1774
12/5/2007
Afluria
Influenza Virus Vaccine
For 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 125254/0 CSL Ltd ACN
45 Poplar Road
Parkville Victoria, 3052
Australia
License No. 1764
9/28/2007
ALBAclone Anti A (LA2)/Blood grouping reagent
Anti-A (Murine Monoclonal)
Licensure of Anti-A (Murine Monoclonal) from the cell line LA2 125129/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ALBAclone Anti B (LB3/Blood grouping reagent
Anti-B (Murine Monoclonal)
Licensure of Anti-B (Murine Monclonal) from cell line LB3 125130/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ALBAclone Anti A,B (LA2/LB3/ES15)/ Blood grouping reagent
Anti-A,B (Murine Monoclonal)
Licensure of Anti-A,B (Murine Monoclonal) from the cell lines LA2, LB3, ES15 125131/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-D Alpha (LDM1) (LDM3)/ Blood grouping reagent
Anti-D (Monoclonal) (IgM)
Licensure of Blood Grouping Reagents Anti-D (Monoclonal)(IgM) from the cell line LDM1 and from the cell line LDM3 125132/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-E (DEM1)/Blood grouping reagent
Anti-E (Monoclonal)
Licensure of Anti-E (Human/Murine Monoclonal) from the cell line DEM1 125133/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-c (H48)/Blood grouping reagent
Anti-c (Monoclonal)
Licensure of Anti-c (Human/Murine Monoclonal) from the cell line H48 125134/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-k (cellano) (LKL1)/Blood grouping reagent
Anti-k (Murine Monoclonal)
Licensure of Anti-k (cellano)(Murine Monoclonal) from the cell line LKL1 125135/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-M (LM1)/Blood grouping reagent
Anti-M (Murine Monoclonal)
Licensure of Anti-M (Murine Monoclonal) from the cell line LM1 125136/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-N (LN3)/Blood grouping reagent
Anti-N (Murine Monoclonal)
Licensure of Anti-N (Murine Monoclonal) from the cell line LN3 125137/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-Lea (LEA2)/Blood grouping reagent
Anti-Lea (Murine Monoclonal)
Licensure of Anti-Lea (Murine Monoclonal) from the cell line LEA2 125138/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-Leb (LEB2)/Blood grouping reagent
Anti-Leb (Murine Monoclonal)
Licensure of Anti-Leb (Murine Monoclonal) from the cell line LEB2 125139/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ABLAclone Anti-Lub (LU2)/Blood grouping reagent
Anti-Lub (Murine Monoclonal)
Licensure of Anti-Lub (Murine Monoclonal) from the cell line LU2 125140/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ALBAclone Anti-D Optimun (LDM1/ESD1-M)/Blood grouping reagent
Anti-D (Monoclonal)(IgM Blend)
Licensure of Anti-D (Monoclonal)(IgM Blend) from the cell lines LDM1/ESD1-M 125143/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ALBAclone Anti-D Blend (LDM3/ESD1)/Blood grouping reagent
Anti-D (Monoclonal Blend)
Licensure of Anti-D (Monoclonal Blend) from the cell lines LDM3/ESD1 125144/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723
9/14/2007
ACAM2000
Smallpox (Vaccinia) Vaccine, Live
Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection 125158/0 Acambis Inc.
38 Sidney Street
Cambridge, MA 02139
License No. 1733
8/31/2007
cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system
West Nile Virus / Nucleic Acid, Pooled Testing/Synthetic [cobas TaqScreen West Nile Virus Test]
For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. 125245/0 Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94566-0990
License 1636
8/28/2007
Evithrom
Thrombin, Topical (Human)
An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical 125247/0 OMRIX Biopharmaceuticals, Ltd.
113 SE 5th St.
Oak Island, NC 28465
License 1603
8/27/2007
Privigen
Immune Globulin Intravenous (Human), 10% Liquid
For treatment of Primary Immunodeficiency and treatment of chronic Immune Thrombocytopenic Purpura 125201/0 CSL Behring AG
1020 First Avenue
King of Prussia, PA 19406-0901
License 1766
7/26/2007
ABBOTT PRISM HCV
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)
For the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens 103762/0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Road
Chicago, IL 60064
License 0043
7/11/2007
Source Plasma S/D/T platelet pheresis, leukocytes reduced and concurrent FFP, using COBE Trima Accel Collection System 125120/0 Cumberland County Hospital System, Inc.
3357 Village Dr
Suite 150
Fayetteville, NC 20304-2000
License 1715
6/21/2007
Influenza Virus Vaccine, H5N1 For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine 125244/0 Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725
4/17/2007
HepaGam B
Hepatitis B Immune Globulin Intravenous (Human)
For the prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Also indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection. 125237/0 Cangene Corp
155 Innovation Dr.
Winnipeg, Manitoba
Canada
License 1201
4/6/2007
CEPROTIN
Protein C Concentrate (Human)
For patients with Severe Congenital Protein C Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans 125234/0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 140
3/30/2007
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay) Detection of Hepatitis C Virus RNA in Human Source Plasma samples by PCR 125101/0 BioLife Plasma Services, L.P.
One Baxter Pkwy
DF3-1E
Deerfield, IL 60015
License 1640
2/9/2007
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR 125100/0 BioLife Plasma Services L.P.
One Baxter Pkwy
DF3-1E
Deerfield, IL 60015
License 1640
1/31/2007
Source Plasma Merger of 14 different licensed establishments (owned by Grifols) 125250/0 PlasmaCare, Inc.
1128 Main St., Suite 300
Cincinnati, OH 45202
License 1756
1/29/2007