2006 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 | For further manufacture | 125246 / 0 | Talecris Plasma Resources, Inc. 79 T.W. Alexander Dr 4101 Research Commons Research Triangle Park, NC License 1757 |
12/20/2006 |
| ORTHO T. cruzi ELISA Test System Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen |
Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating | 125161 / 0 | Ortho-Clinical Diagnostics, Inc 1001 US Highway 202 Raritan, NJ 08869-0606 License 1236 |
12/13/2006 |
| Albumin (Human) | Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate | 125154 / 0 | Octapharma Pharmazeutika Produktionsgesm.b.H Oberlaaer Strasse 235 A-1100 Vienna, Austria License 1646 |
10/17/2006 |
| FluLaval 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 contained in the vaccine | 125163 / 0 | ID Biomedical Corporation of Maryland 6996 Columbia Gateway Drive, Suite 103 Columbia , MD 21046-3303 License 1739 |
10/5/2006 |
| Procleix Ultrio Nucleic Acid Test (NAT) for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA |
Qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in plasma and serum specimens from individual human donors, including donors of whole blood and blood components, source plasma and other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. | 125113 / 0 | Gen-Probe, Inc 10210 Genetic Center Drive San Diego, California 92121 License 1592 |
10/3/2006 |
| ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) |
The ABBOTT PRISM HBsAg is intended to be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. ABBOTT PRISM HBsAg Confirmatory assay is an in vitro qualitative chemiluminescent (ChLIA) used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization. The ABBOTT PRISM HBsAg Confirmatory assay is intended for confirmation of samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay. |
103766 / 0 | Abbott Laboratories D-49C, AP6C/2 100 Abbott Park Road Chicago, IL 60064 License 0043 |
7/18/2006 |
| GARDASIL Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
Vaccination in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:
|
125126 / 0 | Merck & Co., Inc Sumneytown Pike P.O. Box 4, BLB-22 West Point, PA 19486-0004 License 0002 |
6/8/2006 |
| Zostavax Zoster Vaccine, Live, (OKA/MERCK) |
Prevention of herpes zoster (shingles) in individuals 60 years of age and older when administered as a single-dose | 125123 / 0 | Merck & Co., Inc Sumneytown Pike P.O. Box 4, BLB-22 West Point, PA 19486-0004 License 0002 |
5/25/2006 |
| Source Plasma | For further manufacture | 125149 / 0 | Richmond Blood Plasma, LLC dba PlasmaCare 117 3rd St Richmond, VA 23219 License 1729 |
5/12/2006 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks | 125122 / 0 | Merck & Co., Inc Sumneytown Pike P.O. Box 4, BLB-22 West Point, PA 19486-0004 License 0002 |
2/3/2006 |
| HepaGam B Hepatitis B Immune Globulin (Human) |
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 | 125035 / 0 | Cangene Corp 104 Chancellor Matheson Rd Winnipeg, Manitoba R3T 5Y3 Canada License 1201 |
1/27/2006 |
| Vivaglobin Immune Globulin Subcutaneous (Human) |
Treatment of patients with primary immune deficiency (PID) | 125115 / 0 | ZLB Behring, L.L.C. 1020 First Avenue King of Prussia, PA 19406-0901 License 1708 |
1/9/2006 |
| Source Plasma | For further manufacture | 125114 / 0 | Whitehall Blood Plasma, LLC 3840 East Main St Whitehall, Ohio 43213 License 1712 |
1/5/2006 |