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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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 UseSTNManufacturer/
License Number
Approval Date
Source PlasmaFor further manufacturing125064/0International BioResources, LLC
7428 E. Stetson Drive
Suite 110
Scottsdale, AZ 85251
License 1655
3/13/2003
EVICEL
Fibrin Sealant (Human)
Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical125010/0OMRIX 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 infection103901/0Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
License 1236
4/23/2003
Source PlasmaFor further manufacturing125074/0DCI 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 age125020/0MedImmune Vaccines, Inc
297 North Bernardo Ave
Mountain View, CA 94043
License 1652
6/17/2003
Source PlasmaFor further manufacturing125069/0DCI 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 emphysema125078/0Aventis 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 A125063/0Baxter 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 2125030/0Bio-Rad Laboratories, Inc
4000 Alfred Nobel Drive
Hercules, CA 94547
License 1109
8/5/2003
Source PlasmaFor further manufacturing125071/0Portsmouth Blood Plasma, LLC
1128 Main Street
Cincinnati, OH 45202
License 1658
8/7/2003
Source PlasmaFor further manufacturing125032/0BSC 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 purpura125046/0Bayer 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 botulinum125034/0California 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 UsePrimary and booster immunization of persons 7 - 59 years of age against tetanus and diphtheria103171/0Aventis Pasteur Ltd
1755 Steeles Avenue West
Toronto, Ontario
License 1280
11/3/2003
Source PlasmaFor further manufacturing125079/0Hampton 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 disorders125077/0Instituto Grifols, SA
Barcelona, Spain
License 1181
12/15/2003