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.
Transfer of Therapeutic Products to CDER
| 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 |