1998 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 | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|
| Source Plasma | For further manufacture | Community Blood Centers of South Florida, Inc 1700 North State Rd 7 Lauderhill, FL 33313 License 0913 |
1/6/1998 |
| Source Plasma | For further manufacture | Seramed, Inc 780 Park North Blvd Clarkston, GA 30021 License 1237 |
1/16/1998 |
| HTLV-I p21E Antigen Human T-Lymphotropic Virus I & II |
Shared manufacturing arrangement with Organon Teknika Corp | Organon Teknika BV Boseind 15 5281 RM Boxtel NETHERLANDS License 1103 |
1/17/1998 |
| Vironostika HTLV-I & II Microelisa System Human T-Lymphotropic Virus I & II |
Used for detection of antibodies to HTLV-I/II in human serum or plasma | Organon Teknika Corp 100 Akzo Avenue Durham, NC 27712 License 0956 |
1/17/1998 |
| Whole Blood | Transfusion | Dept. of Veterans Affairs Medical and Regional Office Center Blood Bank Dept 1 VA Center Togus, ME 04330 License 1240 |
3/19/1998 |
| Tisseel VH Kit Fibrin Sealant |
Used as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by onventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; and for closure of colostomies | Osterreichisches Institut fur Haemoderivate Ges.m.b.H. Industriestrasse 67 A-1220 Vienna AUSTRIA License 0258 |
5/1/1998 |
| VIPLAS / SD Pooled Plasma, Solvent Detergent Treated |
For use in the treatment of patients with documented deficiencies of coagulation factors for which there are no concentrate preparations available, including congenital single-factor deficiencies of factors I, V, VII, XI, and XIII, and acquired multiple coagulation factor deficiencies; reversals of warfarin effect; and treatment of patients with thrombotic thrombocytopenic purpura (TTP) | V.I. Technologies, Inc 155 Duryea Road P.O. Box 5119 Melville, NY 11747 License 0386 |
5/6/1998 |
| Source Plasma | For further manufacture | V.I. Technologies, Inc 155 Duryea Road P.O. Box 5119 Melville, NY 11747 License 0386 |
5/12/1998 |
| Source Plasma | For further manufacture | International Enzymes, Inc 1432-B South Mission Road Fallsbrook, CA 92028 License 1243 |
5/27/1998 |
| Source Leukocytes | For further manufacture | San Diego Blood Bank 440 Upas Street San Diego, CA 92103 License 0201 |
6/26/1998 |
| CERTIVA Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
For the active immunization of persons 6 weeks to 7 years of age (prior to the seventh birthday) | North American Vaccine, Inc 12103 Indian Creek Court Beltsville, MD 20705 License 1254 |
7/29/1998 |
| Diphtheria Toxoid Concentrate (For Further Manufacturing Use) | For further manufacture under shared arrangement with North American Vaccine, Inc | Statens Seruminstitut 5, Artillerivej DK-2300 Copenhagen S DENMARK License 1255 |
7/29/1998 |
| Tetanus Toxoid Concentrate (For Further Manufacturing Use) | For further manufacture under shared arrangement with North American Vaccine, Inc | Statens Seruminstitut 5, Artillerivej DK-2300 Copenhagen S DENMARK License 1255 |
7/29/1998 |
| Source Plasma | For further manufacture | San Diego Blood Bank 440 Upas Street San Diego, CA 92103 License 0201 |
8/19/1998 |
| RotaShield Rotovarus Vaccine, Live, Oral, Tetravalent |
Primary immunization of infants at 2, 4, and 6 months of age | Wyeth Laboratories, Inc Wasp & Biddle Streets P.O. Box 34 Marietta, PA 17547 License 0003 |
8/31/1998 |
| Cryoprecipitated AHF | Transfusion | Northern Illinois Blood Bank, Inc 419 North Sixth Street Rockford, IL 61107 License 0249 |
9/1/1998 |
| Red Blood Cells | Transfusion | Arizona Blood Institute, Inc 3915 East Broadway Blvd Tucson, AZ 86711 License 1225 |
10/8/1998 |
| Source Plasma | For further manufacture | West Tennessee Regional Blood Center, Inc 828 North Parkway Jackson, TN 38305 License 0170 |
11/4/1998 |
| Whole Blood | Transfusion | Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263 |
12/17/1998 |
| Red Blood Cells | Transfusion | Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263 |
12/17/1998 |
| Platelets | Transfusion | Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263 |
12/17/1998 |
| LYMErix Lyme Disease Vaccine (Recombinant OspA) |
Active immunization against Lyme disease in individuals aged 15-70 years | SmithKline Beecham Biologicals Rue de l'Institut 89 B-1330 Rixensart BELGIUM License 1090 |
12/21/1998 |
| Whole Blood | Transfusion | Gateway Community Blood Program, Inc 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264 |
12/24/1998 |
| Red Blood Cells | Transfusion | Gateway Community Blood Program, Inc 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264 |
12/24/1998 |
| Plasma | Transfusion | Gateway Community Blood Program, Inc 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264 |
12/24/1998 |
| Platelets | Transfusion | Gateway Community Blood Program, Inc 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264 |
12/24/1998 |
| Thymoglobulin Anti-thymocyte Globulin (Rabbit) |
Treatment of acute rejection in renal transplant patients | Pasteur Meriex Serums et Vaccins, S.A. 58 Avenue Leclerc 69007 Lyon FRANCE License 0384 |
12/30/1998 |