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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1996 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 UseManufacturer/
License Number
Approval Date
Blood Grouping Reagent (Monoclonal) (For Further Manufacturing Use)Shared manufacturing arrangement with Immucor, IncSanofi Diagnostics Pasteur, SA
Parc Hightec 9 Avenue du Canada Batiment LATITUDE-B.P.354
91966 LES ULIS CEDEX
FRANCE
License 1198
1/3/1996
Respigam
Respiratory Syncytial Virus Immune Globulin Intravenous (Human)
Prevention of serious lower respiratory tract infection in children less than 24 months of ageMassachusetts Public Health Biologic Labs
305 South Street
Boston, MA 02130
License 0064
1/18/1996
Source PlasmaFor further manufactureBioMune Corp
Post Office Box 310701
Boca Raton, FL 33431-0701
License 1200
2/5/1996
Red Blood CellsTransfusionSouth Bend Medical Foundation, Inc
530 N. Lafayette Blvd
South Bend, IN 46601
License 0248
3/5/1996
PlasmaTransfusionCommunity Blood Bank of Lancaster County
Medical Society
2966 "O" Street
Lincoln, NE 68510
License 0695
3/5/1996
Coulter HIV-1 p24 Antigen Assay Neutralization Kit
Antibody to HIV-1 p24 Antigen (Murine Monoclonal)
In-vitro diagnostic test kit used in the detection of HIV Type 1 AntigenCoulter Corp
MC 31-B06, P.O. Box 169015
Miami, FL 33116-9015
License 1185
3/14/1996
PlasmaTransfusionBlood Bank of the Redwoods
2324 Bethards Dr
Santa Rosa, CA 95405-8537
License 0197
3/15/1996
VAQTA
Heptatitis A Vaccine Inactivated
Immunization against hepatitis A in children over 6 years of ageMerck & Co, Inc
Sumneytown Pike
West Point, PA 19486
License 0002
3/29/1996
Reverse-Cyte
Reagent Red Blood Cells
In vitro diagnostic test kitDade AG
Bonnstrasse 9
3186 Dudingen
SWITZERLAND
License 1138
4/3/1996
PlateletsTransfusionBlood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226
4/25/1996
Source LeukocytesTransfusionFlorida Georgia Blood Blood Alliance, Inc
536 West 10th Street
Jacksonville, FL 32206
License 0181
5/6/1996
Source PlasmaFor further manufactureGreen Street Biologicals, Inc
105 Chapel Drive
Lafayette, LA 70506
License 1203
5/6/1996
Cryoprecipitated AHFTransfusionCentral Blood Bank
812 Fifth Avenue
Pittsburgh, PA 15219
License 0234
6/26/1996
Cryoprecipitated AHFTransfusionCivitan Regional Blood Center, Inc
1221 NW 13th Street
Gainesville, FL 32601
License 0843
6/26/1996
Immu-4 Bulk (For Further Manufacturing Use)Shared manufacturing arrangement with Immunomedics, IncCharles River Div.of Wilmington Partners, LP
251 Ballardvale Street
Wilmington, MA 01887
License 1206
6/28/1996
PlasmaTransfusionBlood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226
8/6/1996
Calypte HIV-1 Urine EIA
HIV-Type 1 (Recombinant)
In vitro diagnostic test kit used in the detection of antibodies to HIV-1 present in urineCalypte Biomedical Corp
1440 Fourth Street,
Berkeley, CA 94701
License 1207
8/6/1996
Antihemophilic Factor (Human)Treatment of patients with hemophilia ACenteon Pharma GmbH
Post Office Box 1230
D-35002 Marburg
GERMANY
License 1202
8/22/1996
PlasmaTransfusionAm-Rho Laboratories,Inc
780 N. Park Blvd
Suite 100
Clarkston, GA 30021
License 0991
8/22/1996
Therapeutic Exchange PlasmaCollection of plasma from patients diagnosed with Guillain-Barre and who have developed high titers of IgM antibody to CytomegalovirusCommunity Blood Center of Greater Kansas City
4040 Main Street
Kansas City, MO 64111
License 0302
9/3/1996
Whole BloodTransfusionSitka Community Hospital
209 Moller Street
Sitka, AK 99835
License 1210
9/3/1996
RSV High Titer Fraction II+III Paste (For Further Manufacturing Use)Shared manufacturing arrangement with Massachusetts Public Health Biologic LabsBaxter Heathcare Corp
305 South Street
Boston, MA 02130
License 0140
9/10/1996
COMVAX
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Immunization of persons 6 weeks to 15 months of age born of Hepatitis B Surface Antigen (HBsAg) negative mothersMerck & Co, Inc
Sumneytown Pike
West Point, PA 19486
License 0002
10/2/1996
Cryoprecipitated AHFControl bleeding associated with Factor VIII deficiencyBlood Bank of the Redwoods
2324 Bethards Drive
Santa Rosa, CA
95405-8537
License 0197
10/3/1996
Whole BloodTransfusionSouth East Alaska Regional Health Consortium
222 Tongass Drive
Sitka, AK 99835
License 1212
10/10/1996
Whole BloodTransfusionLittleton Regional Hospital
107 Cottage Street
Littleton, NH 03561
License 1213
10/10/1996
Red Blood CellsTransfusionLittleton Regional Hosptial
107 Cottage Street
Littleton, NH 03561
License 1213
10/10/1996
Source PlasmaFor Further ManufactureDecatur Plasma, Inc
105 Chapel Drive
Lafayette, LA 70506
License 1214
10/21/1996
Source PlasmaFor Further ManufactureAtopix Pharma Corp
5375 Avenida Encinas
Suite B
Carlsbad, CA 92008
License 1215
10/21/1996
Source LeukocytesTransfusionThe Blood Center of New Jersey, Inc
45 South Grove St
East Orange, NJ 07018
License 0221
11/13/1996
PlasmaTransfusionPuget Sound Blood Center
921 Terry Avenue
Seattle, WA 98104
License 0192
11/21/1996
Source PlasmaFor further manufactureClinical Research Technologies
12095 W. Washington Boulevard
Los Angeles, CA 90066
License 1217
12/11/1996
UBI HIV 1/2 EIA
Human Immuno-deficiency test to detect Virus Types 1 & 2
In vitro diagnostic antibodies to HIV 1/2 in human serum or plasmaUnited Biomedical, Inc
25 Davids Drive
Hauppauge, NY 11788
License 1079
12/20/1996
Cryoprecipitated AHFTransfusionBlood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226
12/26/1996
Cryoprecipitated AHFTransfusionBlood Bank of San Bernardino and Pooled Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226
12/26/1996
Source PlasmaFor further manufactureCal Plasma Center, LLC
105 Chapel Drive
Lafayette, LA 70506
License 1219
12/26/1996
Cryoprecipitated AHFTransfusionInova Health Care Services
3289 Woodburn Road, Suite 10
Annandale, VA 22003
License 0365
12/26/1996
Source PlasmaFor further manufactureSeraCare, Inc
1925 Century Park East, Suite 1970
Los Angeles, CA 90067
License 1218
12/26/1996