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.
- Complete List of Currently Licensed Products and Establishments
- Transfer of Therapeutic Products to CDER
Note: Approvals are listed with the most recent action at the top.
| 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 |