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.
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 |
|---|---|---|---|---|
| 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:
|
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 |