1997 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 | Nations Biologics,Inc 1900 Lafayette St Gretna, LA 70053 License 1221 |
1/17/1997 |
| Diphtheria & Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) | For further manufacture under shared arrangement with SmithKline Beecham Biologicals | Chiron Behring GmbH & Co P.O. Box 1630 35006 Marburg GERMANY License 1222 |
1/29/1997 |
| Infanrix Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
For primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses | SmithKline Beecham Biologicals, S.A. 89, Rue de l'Institut 1330 Rixensart BELGIUM License 1090 |
1/29/1997 |
| Red Blood Cells | Transfusion | Am-Rho Labs, Inc 780 Park North Boulevard, #110 Clarkston, GA License 0991 |
2/10/1997 |
| Benefix Coagulation Factor IX (Recombinant) |
Control and Prevention of hemorrhagic episodes in patients with hemophilia B, including the perioperative management of hemophilia B patients undergoing surgery | Genetics Institute, Inc 1 Burtt Road Andover, MA License 1163 |
2/11/1997 |
| Cryoprecipitated AHF | Transfusion | Spartanburg Blood Bank, Inc 175 Dunbar Street Spartanburg, SC License 0765 |
2/18/1997 |
| Source Plasma | For further manufacture | Joliet Blood Plasma, LLC 502 N. Capitol Ave Indianapolis, IN 46204 License 1223 |
3/3/1997 |
| Platelets | Transfusion | South Bend Medical Foundation, Inc 530 N. Lafayette Blvd South Bend, IN 46601 License 0248 |
3/7/1997 |
| Source Plasma | For further manufacture | SeraCare Acquisitions, Inc 1925 Century Park East Los Angeles, CA 90067 License 1224 |
3/19/1997 |
| Platelets | Transfusion | Arizona Blood Institute, Inc 3915 E. Broadway Blvd Tucson, AZ 85711 License 1225 |
3/20/1997 |
| Plasma | Transfusion | Arizona Blood Institute, Inc 3915 E. Broadway Blvd Tucson, AZ 85711 License 1225 |
3/20/1997 |
| Diphtheria and Tetanus Toxoids Adsorbed | Immunization of infants and children, 6 weeks to 7 years of age | Connaught Laboratories Ltd 1755 Steeles Avenue West North York Ontario CANADA M2R 3T4 License 0073 |
4/11/1997 |
| Source Plasma | For further manufacture | The Canadian Red Cross Society 1800 Alta Vista Drive Ottawa, ON KIG 4J5 CANADA License 1226 |
5/1/1997 |
| Whole Blood | Transfusion | United States Blood Bank, Inc 130 Ponce de Leon Blvd Coral Gables, FL 33135 License 1229 |
6/23/1997 |
| Red Blood Cells | Transfusion | United States Blood Bank, Inc 130 Ponce de Leon Blvd Coral Gables, FL 33135 License 1229 |
6/23/1997 |
| Plasma | Transfusion | United States Blood Bank, Inc 130 Ponce de Leon Blvd Coral Gables, FL 33135 License 1229 |
6/23/1997 |
| Source Plasma | For further manufacture | Melrose Plasma, LLC 105 Chapel Drive Lafayette, LA 70506 License 1230 |
8/7/1997 |
| Plasma | Transfusion | Serologicals, Inc 780 Park North Blvd Clarkston, GA 30021 License 0963 |
8/7/1997 |
| Red Blood Cells | Transfusion | Serologicals, Inc 780 Park North Blvd Clarkston, GA 30021 License 0963 |
8/7/1997 |
| Whole Blood | Transfusion | Serologicals, Inc 780 Park North Blvd Clarkston, GA 30021 License 0963 |
8/7/1997 |
| Abbott HTLV-I HTLV-III EIA Human T-Lymphotropic Virus Types I and II |
EIA for detection of HTLV-I/HTLV-II antibodies in serum or plasma | Abbott Laboratories D-49C, AP6C/2 Abbott Park Buckley Rd & Waukegan Road North Chicago, IL 60064 License 0043 |
8/15/1997 |
| Carticel SM Service Autologous Cultured Chondrocytes |
Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle | Genzyme Tissue Repair 64 Sidney Street Cambridge, MA 02139 License 1233 |
8/22/1997 |
| Source Plasma | For further manufacture | DCI Biologicals 764 Main Street Dunedin, FL License 1234 |
10/9/1997 |
| RabAvert Rabies Vaccine |
Rabies vaccine for immunization of children and adults | Chiron Behring GmbH P.O. Box 1630 35006 Marburg GERMANY License 1222 |
10/20/1997 |
| Source Leukocytes | For further manufacture | Serologicals, Inc 780 Park North Blvd,Suite 110 Clarkston, GA 30021 License 0963 |
12/9/1997 |