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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1997 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 Nations Biologics,Inc
1900 Lafayette St
Gretna, LA 70053
License 1221
1/17/1997
Diphtheria & Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) For further manufacture under shared arrangement with SmithKline Beecham Biologicals Chiron Behring GmbH & Co
P.O. Box 1630
35006 Marburg GERMANY
License 1222
1/29/1997
Infanrix
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
For primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses SmithKline Beecham
Biologicals, S.A.
89, Rue de l'Institut
1330 Rixensart
BELGIUM
License 1090
1/29/1997
Red Blood Cells Transfusion Am-Rho Labs, Inc
780 Park North
Boulevard, #110
Clarkston, GA
License 0991
2/10/1997
Benefix
Coagulation Factor IX (Recombinant)
Control and Prevention of hemorrhagic episodes in patients with hemophilia B, including the perioperative management of hemophilia B patients undergoing surgery Genetics Institute, Inc
1 Burtt Road
Andover, MA
License 1163
2/11/1997
Cryoprecipitated AHF Transfusion Spartanburg Blood Bank, Inc
175 Dunbar Street
Spartanburg, SC
License 0765
2/18/1997
Source Plasma For further manufacture Joliet Blood Plasma, LLC
502 N. Capitol Ave
Indianapolis, IN 46204
License 1223
3/3/1997
Platelets Transfusion South Bend Medical Foundation, Inc
530 N. Lafayette Blvd
South Bend, IN 46601
License 0248
3/7/1997
Source Plasma For further manufacture SeraCare Acquisitions, Inc
1925 Century Park East
Los Angeles, CA 90067
License 1224
3/19/1997
Platelets Transfusion Arizona Blood Institute, Inc
3915 E. Broadway Blvd
Tucson, AZ 85711
License 1225
3/20/1997
Plasma Transfusion Arizona Blood Institute, Inc
3915 E. Broadway Blvd
Tucson, AZ 85711
License 1225
3/20/1997
Diphtheria and Tetanus Toxoids Adsorbed Immunization of infants and children, 6 weeks to 7 years of age Connaught Laboratories Ltd
1755 Steeles Avenue
West North York
Ontario
CANADA M2R 3T4
License 0073
4/11/1997
Source Plasma For further manufacture The Canadian Red Cross Society
1800 Alta Vista Drive
Ottawa, ON KIG 4J5
CANADA
License 1226
5/1/1997
Whole Blood Transfusion United States Blood Bank, Inc
130 Ponce de Leon Blvd
Coral Gables, FL 33135
License 1229
6/23/1997
Red Blood Cells Transfusion United States Blood Bank, Inc
130 Ponce de Leon Blvd
Coral Gables, FL 33135
License 1229
6/23/1997
Plasma Transfusion United States Blood Bank, Inc
130 Ponce de Leon Blvd
Coral Gables, FL 33135
License 1229
6/23/1997
Source Plasma For further manufacture Melrose Plasma, LLC
105 Chapel Drive
Lafayette, LA 70506
License 1230
8/7/1997
Plasma Transfusion Serologicals, Inc
780 Park North Blvd
Clarkston, GA 30021
License 0963
8/7/1997
Red Blood Cells Transfusion Serologicals, Inc
780 Park North Blvd
Clarkston, GA 30021
License 0963
8/7/1997
Whole Blood Transfusion Serologicals, Inc
780 Park North Blvd
Clarkston, GA 30021
License 0963
8/7/1997
Abbott HTLV-I
HTLV-III EIA

Human T-Lymphotropic Virus Types I and II
EIA for detection of HTLV-I/HTLV-II antibodies in serum or plasma Abbott Laboratories
D-49C, AP6C/2 Abbott Park
Buckley Rd & Waukegan Road
North Chicago, IL 60064
License 0043
8/15/1997
Carticel SM Service
Autologous Cultured Chondrocytes
Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139
License 1233
8/22/1997
Source Plasma For further manufacture DCI Biologicals
764 Main Street
Dunedin, FL
License 1234
10/9/1997
RabAvert
Rabies Vaccine
Rabies vaccine for immunization of children and adults Chiron Behring GmbH
P.O. Box 1630
35006 Marburg
GERMANY
License 1222
10/20/1997
Source Leukocytes For further manufacture Serologicals, Inc
780 Park North Blvd,Suite 110
Clarkston, GA 30021
License 0963
12/9/1997