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.
Transfer of Therapeutic Products to CDER
| 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 |