2003 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 in order by date of approval.
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Source Plasma | For further manufacturing | 125064 / 0 | International BioResources, LLC 7428 E. Stetson Drive Suite 110 Scottsdale, AZ 85251 License 1655 |
3/13/2003 |
| Crosseal Fibrin Sealant (Human) |
Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical | 125010 / 0 | OMRIX biopharmaceuticals, Ltd 200 Chaussee De Waterloo 1640 Rhode-St-Genese, MA 02142 BELGIUM License 1603 |
3/21/2003 |
| ORTHO Antibody to HBsAG ELISA Test System 3 Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) (Antibody to HBsAg/Enzyme Immuno Assay (EIA), Version 3.0/Monoclonal) |
Detection of hepatitis B surface antigen in human serum or plasma as a screening test and an aid in the diagnosis of potential hepatitis B infection | 103901 / 0 | Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606 License 1236 |
4/23/2003 |
| Source Plasma | For further manufacturing | 125074 / 0 | DCI Biologicals Wilmington LLC 509 West Aztec Ave Gallup, NM License 1660 |
5/27/2003 |
| FluMist Influenza Virus Vaccine, Live, Intranasal |
For active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age | 125020 / 0 | MedImmune Vaccines, Inc 297 North Bernardo Ave Mountain View, CA 94043 License 1652 |
6/17/2003 |
| Source Plasma | For further manufacturing | 125069 / 0 | DCI Biologicals Texarkana LLC 903 Arkansas Boulevard Texarkana, TX 71854 License 1657 |
6/27/2003 |
| Zemaira Alpha-1-Proteinase Inhibitor (Human) |
Chronic augmentation and maintenance therapy in individuals with alpha 1-proteinase inhibitor deficiency and evidence of emphysema | 125078 / 0 | Aventis Behring LLC 1020 First Avenue P.O. Box 61501 King of Prussia, PA 19406-0901 License 1281 |
7/8/2003 |
| Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method |
Indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and in the perioperative management of patients with hemophilia A | 125063 / 0 | Baxter Healthcare Corp One Baxter Way Westlake Village, CA 91362 License 0140 |
7/25/2003 |
| Genetic Systems HIV-1/HIV-2 Plus O EIA Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic) |
For detection of antibodies to human immunodeficiency types 1 and 2 | 125030 / 0 | Bio-Rad Laboratories, Inc 4000 Alfred Nobel Drive Hercules, CA 94547 License 1109 |
8/5/2003 |
| Source Plasma | For further manufacturing | 125071 / 0 | Portsmouth Blood Plasma, LLC 1128 Main Street Cincinnati, OH 45202 License 1658 |
8/7/2003 |
| Source Plasma | For further manufacturing | 125032 / 0 | BSC II 3218 Azeele Street Tampa, FL 33609 License 1619 |
8/11/2003 |
| Gamunex Immune Globulin Intravenous (Human), 10% by Chromatography Process |
Indicated in primary humoral immunodeficiency and idiopathic thrombocytopenic purpura | 125046 / 0 | Bayer Corp 800 Dwight Way Berkeley, CA 94710 License 0008 |
8/27/2003 |
| BabyBIG Botulism Immune Globulin Intravenous (Human) |
Treatment of infant botulism caused by type A or type B Clostridium botulinum | 125034 / 0 | California Department of Health Services Cato Research, Ltd 200 Westpark Corporate Center Durham, NC 22713-2280 License 1622 |
10/23/2003 |
| Tetanus and Diphtheria Toxoids Adsorbed For Adult Use | Primary and booster immunization of persons 7 - 59 years of age against tetanus and diphtheria | 103171 / 0 | Aventis Pasteur Ltd 1755 Steeles Avenue West Toronto, Ontario License 1280 |
11/3/2003 |
| Source Plasma | For further manufacturing | 125079 / 0 | Hampton Blood Plasma, LLC 1128 Main Street Cincinnati, OH 45202 License 1686 |
12/8/2003 |
| Flebogamma Immune Globulin Intravenous (Human) |
Replacement therapy in primary (inherited) humoral immune deficiency disorders | 125077 / 0 | Instituto Grifols, SA Barcelona, Spain License 1181 |
12/15/2003 |