1999 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 | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|
| Whole Blood | Transfusion | Winter Haven Hospital, Inc 460 First Street, North Winter Haven, FL 33881 License 1266 |
2/5/1999 |
| Red Blood Cells | Transfusion | Winter Haven Hospital, Inc 460 First Street, North Winter Haven, FL 33881 License 1266 |
2/5/1999 |
| Plasma | Transfusion | Winter Haven Hospital, Inc 460 First Street, North Winter Haven, FL 33881 License 1266 |
2/5/1999 |
| Nabi-HB Hepatitis B Immune Globulin (Human) |
Treatment of acute exposure to 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 HBV infection | Nabi P.O. Box 310701 Boca Raton, FL 33431-0701 License 1022 |
3/24/1999 |
| NovoSeven Coagulation Factor VIIa (Recombinant) |
Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX | Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd DENMARK License 1261 |
3/25/1999 |
| Humate-P Antihemophilic Factor/von Willebrand Factor Complex (Human) |
Used in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia); in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease; and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate | Centeon Pharma GmbH P.O. Box 1230 D-35002 Marburg GERMANY License 1202 |
4/1/1999 |
| Cryoprecipitated AHF | Transfusion | Sarasota Community Blood Bank, Inc 1760 Mound Street Sarasota, FL 34236-7761 License 1122 |
6/14/1999 |
| Plasma | Transfusion | Marathon County Blood Bank, Inc 404 South 3rd Avenue Wausau, WI 54401 License 1093 |
7/16/1999 |
| Cryoprecipitated AHF | Transfusion | Northern California Community Blood Bank 2524 Harrison Avenue Eureka, CA 95501 License 0230 |
7/28/1999 |
| Cryoprecipitated AHF | Transfusion | Central California Blood Center 3445 North First Street Fresno, CA 93726 License 0315 |
8/12/1999 |
| Source Plasma | For further manufacture | DCI Biologicals Bryan, Inc 1706 South 2nd St Gallup, NM 87301 License 1275 |
8/13/1999 |
| Plasma | Transfusion | Northern California Community Blood Bank 2524 Harrison Avenue Eureka, CA 95501 License 0230 |
8/16/1999 |
| Platelets | Transfusion | Marathon County Blood Bank, Inc 404 South Third Avenue Wausau, WI 54401-4639 License 1093 |
9/17/1999 |
| Whole Blood | Transfusion | Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276 |
12/17/1999 |
| Red Blood Cells | Transfusion | Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276 |
12/17/1999 |
| Platelets | Transfusion | Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276 |
12/17/1999 |
| Cryoprecipitated AHF | Transfusion | Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276 |
12/17/1999 |
| Plasma | Transfusion | Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276 |
12/17/1999 |
| Source Plasma | For further manufacture | PlasmaCare, Inc 1128 Main Street Cincinnati, OH 45210 License 1278 |
12/30/1999 |