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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2002 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 STN Manufacturer/
License Number
Approval Date
Procleix
HIV-1 / HCV Assay
Assay for the qualitative detection of human immunodeficiency virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion 103966/0 Gen-Probe, Inc
10210 Genetic Center Drive
San Diego, CA 92121
License 1592
2/27/2002
DAPTACEL
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (DTaP)
Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis 103666/0 Aventis Pasteur Ltd
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
CANADA
License 1280
5/14/2002
Multiple Products:
Human Blood and Blood Components
Transfusion/For Further Manufacture 125037/0 DCI Biologicals Jonesboro, Inc
2309A East Nettleton
Jonesboro, AR 72401
License 1625
7/10/2002
Source Plasma For Further Manufacture 125055/0 DCI Biologicals Inc
Greenville, NJ 07110-1199
License 1645
10/29/2002
Source Plasma For Further Manufacture 125054/0 Marion Blood Plasma, Inc
3620 North Post Road
Indianapolis, IN 46226
License 1643
11/19/2002
COBAS AmpliScreen HCV Test
Hepatitis C Virus
Detecting HCV RNA, in conjunction with licensed test for detecting antibodies to HCV 125045/0 Roche Molecular Systems, Inc
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
License 1636
12/3/2002
Pediarix
Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) & Inactivated Poliovirus Vaccine Combined
Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 103907/0 SmithKline Beecham Biologicals
89, rue de l'Institute
B-1330 Rixensart
BELGIUM
License 1090
12/13/2002
COBAS AmpliScreen HIV-1 Test
Human Immunodeficiency Virus Type 1
Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion 125059/0 Roche Molecular Systems, Inc
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
License 1636
12/20/2002
Aralast
Alpha-1 Proteinase Inhibitor (Human)
Treatment for chronic replacement therapy (augmentation) in patients having congenital deficiency of Alpha-1-Proteinase Inhibitors with clinically evident emphysema 125039/0 Alpha Therapeutic Corp
5555 Valley Blvd
Los Angeles, CA 90032
License 0744
12/23/2002