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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1998 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 Manufacturer/
License Number
Approval Date
Source Plasma For further manufacture Community Blood Centers of South Florida, Inc
1700 North State Rd 7
Lauderhill, FL 33313
License 0913
1/6/1998
Source Plasma For further manufacture Seramed, Inc
780 Park North Blvd
Clarkston, GA 30021
License 1237
1/16/1998
HTLV-I p21E Antigen
Human T-Lymphotropic Virus I & II
Shared manufacturing arrangement with Organon Teknika Corp Organon Teknika BV
Boseind 15 5281 RM
Boxtel
NETHERLANDS
License 1103
1/17/1998
Vironostika HTLV-I & II Microelisa System
Human T-Lymphotropic Virus I & II
Used for detection of antibodies to HTLV-I/II in human serum or plasma Organon Teknika Corp
100 Akzo Avenue
Durham, NC 27712
License 0956
1/17/1998
Whole Blood Transfusion Dept. of Veterans Affairs
Medical and Regional Office Center Blood Bank Dept
1 VA Center
Togus, ME 04330
License 1240
3/19/1998
Tisseel VH Kit
Fibrin Sealant
Used as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by onventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; and for closure of colostomies Osterreichisches Institut fur Haemoderivate Ges.m.b.H.
Industriestrasse 67
A-1220 Vienna
AUSTRIA
License 0258
5/1/1998
VIPLAS / SD
Pooled Plasma, Solvent Detergent Treated
For use in the treatment of patients with documented deficiencies of coagulation factors for which there are no concentrate preparations available, including congenital single-factor deficiencies of factors I, V, VII, XI, and XIII, and acquired multiple coagulation factor deficiencies; reversals of warfarin effect; and treatment of patients with thrombotic thrombocytopenic purpura (TTP) V.I. Technologies, Inc
155 Duryea Road
P.O. Box 5119
Melville, NY 11747
License 0386
5/6/1998
Source Plasma For further manufacture V.I. Technologies, Inc
155 Duryea Road
P.O. Box 5119
Melville, NY 11747
License 0386
5/12/1998
Source Plasma For further manufacture International Enzymes, Inc
1432-B South Mission Road
Fallsbrook, CA 92028
License 1243
5/27/1998
Source Leukocytes For further manufacture San Diego Blood Bank
440 Upas Street
San Diego, CA 92103
License 0201
6/26/1998
CERTIVA
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
For the active immunization of persons 6 weeks to 7 years of age (prior to the seventh birthday) North American Vaccine, Inc
12103 Indian Creek Court
Beltsville, MD 20705
License 1254
7/29/1998
Diphtheria Toxoid Concentrate (For Further Manufacturing Use) For further manufacture under shared arrangement with North American Vaccine, Inc Statens Seruminstitut
5, Artillerivej
DK-2300
Copenhagen S
DENMARK
License 1255
7/29/1998
Tetanus Toxoid Concentrate (For Further Manufacturing Use) For further manufacture under shared arrangement with North American Vaccine, Inc Statens Seruminstitut
5, Artillerivej
DK-2300
Copenhagen S
DENMARK
License 1255
7/29/1998
Source Plasma For further manufacture San Diego Blood Bank
440 Upas Street
San Diego, CA 92103
License 0201
8/19/1998
RotaShield
Rotovarus Vaccine, Live, Oral, Tetravalent
Primary immunization of infants at 2, 4, and 6 months of age Wyeth Laboratories, Inc
Wasp & Biddle Streets
P.O. Box 34
Marietta, PA 17547
License 0003
8/31/1998
Cryoprecipitated AHF Transfusion Northern Illinois Blood Bank, Inc
419 North Sixth Street
Rockford, IL 61107
License 0249
9/1/1998
Red Blood Cells Transfusion Arizona Blood Institute, Inc
3915 East Broadway Blvd
Tucson, AZ 86711
License 1225
10/8/1998
Source Plasma For further manufacture West Tennessee Regional Blood Center, Inc
828 North Parkway
Jackson, TN 38305
License 0170
11/4/1998
Whole Blood Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263
12/17/1998
Red Blood Cells Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263
12/17/1998
Platelets Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263
12/17/1998
LYMErix
Lyme Disease Vaccine (Recombinant OspA)
Active immunization against Lyme disease in individuals aged 15-70 years SmithKline Beecham Biologicals
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
License 1090
12/21/1998
Whole Blood Transfusion Gateway Community Blood Program, Inc
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264
12/24/1998
Red Blood Cells Transfusion Gateway Community Blood Program, Inc
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264
12/24/1998
Plasma Transfusion Gateway Community Blood Program, Inc
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264
12/24/1998
Platelets Transfusion Gateway Community Blood Program, Inc
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264
12/24/1998
Thymoglobulin
Anti-thymocyte Globulin (Rabbit)
Treatment of acute rejection in renal transplant patients Pasteur Meriex Serums et Vaccins, S.A.
58 Avenue Leclerc
69007 Lyon
FRANCE
License 0384
12/30/1998