• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

2001 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
Multiple Products:
Human Blood and Blood Components
Transfusion/For Further Manufacture 125026/0 DCI Biologicals Flagstaff, Inc
1706 South 2nd Street
Gallup, NM 87301
License 1612
1/17/2001
Multiple Products:
Human Blood and Blood Components
Transfusion/For Further Manufacture 103903/0 DCI Biologicals Orlando, Inc
22 West Lake Beauty Drive
Orlando, FL 32806
License 1286
1/19/2001
TWINRIX
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine
Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus 103850/0 SmithKline Beecham Biologicals
89, Rue de l'Institut
B-1330 Rixensart
BELGIUM
License 1090
5/11/2001
Multiple Products:
Human Blood and Blood Components
Transfusion / For Further Manufacture 103952/0 Coral Blood Services
300 Professional Drive
Scarborough, ME 04074
License 1590
5/22/2001
Multiple Products:
Human Blood and Blood Components
Transfusion / For Further Manufacture 103965/0 DCI Biologicals Nacogdoches, Inc
1706 S. 2nd Street
Gallup, NM 87301
License 1591
7/10/2001
DigiFab
Digoxin Immune Fab (Ovine)
Treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose 103910/0 Protherics Inc
1207 17th Avenue S., Suite 103
Nashville, TN 37212
License 1575
8/31/2001
UltraQual HCV RT-PCR Assay
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
A nucleic acid test used to detect HCV-RNA in pooled human Source Plasma 103868/0 National Genetics Institute
2440 S. Sepulveda Blvd #130
Los Angeles, CA 90064
License 1582
9/18/2001
UltraQual
HIV-1 RT-PCR Assay

Human Immunodeficiency Type 1 Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
A nucleic acid test used to detect HIV-1-RNA in pooled human Source Plasma 103902/0 National Genetics Institute
2440 S. Sepulveda Blvd #130
Los Angeles, CA 90064
License 1582
9/18/2001
Multiple Products:
Human Blood and Blood Components
Transfusion/For Further Manufacture 103793/0 Central Pennsylvania Blood Bank
Liberty Centre Office Complex
8170 Adams Drive, Suite 100
Hummelstown, PA 17036
License 1576
10/12/2001
Nabi-HB
Hepatitis B Immune Globulin (Human)
Treatment of acute exposure to HBsAg following acute exposure to blood containing 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 hepatitis B virus infection 103945/0 Nabi
5800 Park of Commerce Blvd, NW
Boca Raton, FL 33487
License 1022
10/23/2001
Multiple Products:
Human Blood and Blood Components
Transfusion/For Further Manufacture 125040/0 Price Hill Blood Plasma, Inc
3711 Warsaw Avenue
Cincinnati, OH 45210
License 1621
12/4/2001