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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.


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:
  • Cervical cancer
  • Genital warts (condyloma acuminata)
    and the following precancerous or dysplastic lesions:
  • Cervical adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
  • Cervical intraepithelial neoplasia (CIN) grade 1
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