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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1999 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
Whole Blood Transfusion Winter Haven Hospital, Inc
460 First Street, North
Winter Haven, FL 33881
License 1266
2/5/1999
Red Blood Cells Transfusion Winter Haven Hospital, Inc
460 First Street, North
Winter Haven, FL 33881
License 1266
2/5/1999
Plasma Transfusion Winter Haven Hospital, Inc
460 First Street, North
Winter Haven, FL 33881
License 1266
2/5/1999
Nabi-HB
Hepatitis B Immune Globulin (Human)
Treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute HBV infection Nabi
P.O. Box 310701
Boca Raton, FL 33431-0701
License 1022
3/24/1999
NovoSeven
Coagulation Factor VIIa (Recombinant)
Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX Novo Nordisk A/S
Novo Alle
DK-2880 Bagsvaerd
DENMARK
License 1261
3/25/1999
Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Used in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia); in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease; and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Centeon Pharma GmbH
P.O. Box 1230
D-35002 Marburg
GERMANY
License 1202
4/1/1999
Cryoprecipitated AHF Transfusion Sarasota Community Blood Bank, Inc
1760 Mound Street
Sarasota, FL 34236-7761
License 1122
6/14/1999
Plasma Transfusion Marathon County Blood Bank, Inc
404 South 3rd Avenue
Wausau, WI 54401
License 1093
7/16/1999
Cryoprecipitated AHF Transfusion Northern California Community Blood Bank
2524 Harrison Avenue
Eureka, CA 95501
License 0230
7/28/1999
Cryoprecipitated AHF Transfusion Central California Blood Center
3445 North First Street
Fresno, CA 93726
License 0315
8/12/1999
Source Plasma For further manufacture DCI Biologicals Bryan, Inc
1706 South 2nd St
Gallup, NM 87301
License 1275
8/13/1999
Plasma Transfusion Northern California Community Blood Bank
2524 Harrison Avenue
Eureka, CA 95501
License 0230
8/16/1999
Platelets Transfusion Marathon County Blood Bank, Inc
404 South Third Avenue
Wausau, WI 54401-4639
License 1093
9/17/1999
Whole Blood Transfusion Community Blood Center
Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276
12/17/1999
Red Blood Cells Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276
12/17/1999
Platelets Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276
12/17/1999
Cryoprecipitated AHF Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276
12/17/1999
Plasma Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276
12/17/1999
Source Plasma For further manufacture PlasmaCare, Inc
1128 Main Street
Cincinnati, OH 45210
License 1278
12/30/1999