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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2005 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
Procleix WNV Assay
West Nile Virus Assay
Qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors; testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. 125121/0 Gen-Probe Inc
10210 Genetic Center Drive
San Diego, CA 92121
License 1592
12/1/2005
ABBOTT PRISM HBcore
Hepatitis B Virus Core Antigen (E.coli, Recombinant)
Qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma; screening test for blood and plasma to prevent transmission of hepatitis B virus (HBV) to recipients of blood and blood components 103785/0 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
License 0043
10/13/2005
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
For vaccination against measles, mumps, rubella, and varicella in children 12 months to 12 years of age 125108/0 Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
9/6/2005
Fluarix
Influenza Virus Vaccine
For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B 125127/0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
8/31/2005
Component of Erytype S
Blood Grouping Reagent, Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A,B (Murine Monoclonal Blend); Anti-D (Monoclonal) (IgM)
To perform a single ABO Grouping and D Typing or label confirmation for donor ABO Grouping and/or D Typing (for exclusive use on the Tango Automated Analyzer) 125094/0
125095/0
125096/0
125097/0
Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Germany
License 1702
7/26/2005
Anti-Human Globulin Solidscreen II
Anti-Human Globulin, Anti-IgG (Rabbit)
To detect the sensitization of Reagent Red Blood Cells by immunoglobulins (for exclusive use on the Tango Automated Analyzer) 125098/0 Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Germany
License 1702
7/26/2005
Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age 125111/0 Aventis Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada MSR 3T4
License 1280
6/10/2005
Tetanus Toxoid Concentrate (For Further Manufacturing Use) For further manufacture to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with GlaxoSmithKline Biologicals 125107/0 Chiron Behring GmbH & Co
P.O. Box 1630
35006 Marburg
Germany
License 1222
5/3/2005
Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Booster immunization against tetanus, diphtheria and pertussis as a single dose in adolescents 10-18 years of age 125106/0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
5/3/2005
Vaccinia Immune Globulin Intravenous (Human) Treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination:
  • Eczema vaccinatum
  • Progressive vaccinia
  • Severe generalized vaccinia
  • Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
  • Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard
125109/0 Cangene Corp
104 Chancellor Matheson Road
Winnipeg, Manitoba
Canada R3T5Y3
License 1201
5/2/2005
Gammagard Liquid
Immune Globulin Intravenous (Human), 10% Solution
Liquid dosage form for primary immune deficiency 125105/0 Baxter HealthCare Corp
One Baxter Way
Westlake Village, CA 91362
License 140
4/27/2005
COBAS AmpliScreen HBV Test
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived)
Qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma, as well as for testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) 125090/0 Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, CA 94588-2722
License 1636
4/21/2005
Thrombin (Human) (For Further Manufacturing Use) For further manufacturing with FloSeal Matrix Hemostatic Sealant 125091/0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 0140
2/18/2005
Vaccinia Immune Globulin Intravenous (Human) For the treatment and modification of aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard; eczema vaccinatum; progressive vaccinia; severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions 125093/0 DynPort Vaccine Company LLC
64 Thomas Johnson Drive
Frederick, MD 21702
License 1700
2/18/2005
Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
For active immunization of adolescents and adults 11-55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 125089/0 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
1/14/2005