1996 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 |
|---|---|---|---|
| Blood Grouping Reagent (Monoclonal) (For Further Manufacturing Use) | Shared manufacturing arrangement with Immucor, Inc | Sanofi Diagnostics Pasteur, SA Parc Hightec 9 Avenue du Canada Batiment LATITUDE-B.P.354 91966 LES ULIS CEDEX FRANCE License 1198 |
1/3/1996 |
| Respigam Respiratory Syncytial Virus Immune Globulin Intravenous (Human) |
Prevention of serious lower respiratory tract infection in children less than 24 months of age | Massachusetts Public Health Biologic Labs 305 South Street Boston, MA 02130 License 0064 |
1/18/1996 |
| Source Plasma | For further manufacture | BioMune Corp Post Office Box 310701 Boca Raton, FL 33431-0701 License 1200 |
2/5/1996 |
| Red Blood Cells | Transfusion | South Bend Medical Foundation, Inc 530 N. Lafayette Blvd South Bend, IN 46601 License 0248 |
3/5/1996 |
| Plasma | Transfusion | Community Blood Bank of Lancaster County Medical Society 2966 "O" Street Lincoln, NE 68510 License 0695 |
3/5/1996 |
| Coulter HIV-1 p24 Antigen Assay Neutralization Kit Antibody to HIV-1 p24 Antigen (Murine Monoclonal) |
In-vitro diagnostic test kit used in the detection of HIV Type 1 Antigen | Coulter Corp MC 31-B06, P.O. Box 169015 Miami, FL 33116-9015 License 1185 |
3/14/1996 |
| Plasma | Transfusion | Blood Bank of the Redwoods 2324 Bethards Dr Santa Rosa, CA 95405-8537 License 0197 |
3/15/1996 |
| VAQTA Heptatitis A Vaccine Inactivated |
Immunization against hepatitis A in children over 6 years of age | Merck & Co, Inc Sumneytown Pike West Point, PA 19486 License 0002 |
3/29/1996 |
| Reverse-Cyte Reagent Red Blood Cells |
In vitro diagnostic test kit | Dade AG Bonnstrasse 9 3186 Dudingen SWITZERLAND License 1138 |
4/3/1996 |
| Platelets | Transfusion | Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226 |
4/25/1996 |
| Source Leukocytes | Transfusion | Florida Georgia Blood Blood Alliance, Inc 536 West 10th Street Jacksonville, FL 32206 License 0181 |
5/6/1996 |
| Source Plasma | For further manufacture | Green Street Biologicals, Inc 105 Chapel Drive Lafayette, LA 70506 License 1203 |
5/6/1996 |
| Cryoprecipitated AHF | Transfusion | Central Blood Bank 812 Fifth Avenue Pittsburgh, PA 15219 License 0234 |
6/26/1996 |
| Cryoprecipitated AHF | Transfusion | Civitan Regional Blood Center, Inc 1221 NW 13th Street Gainesville, FL 32601 License 0843 |
6/26/1996 |
| Immu-4 Bulk (For Further Manufacturing Use) | Shared manufacturing arrangement with Immunomedics, Inc | Charles River Div.of Wilmington Partners, LP 251 Ballardvale Street Wilmington, MA 01887 License 1206 |
6/28/1996 |
| Plasma | Transfusion | Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226 |
8/6/1996 |
| Calypte HIV-1 Urine EIA HIV-Type 1 (Recombinant) |
In vitro diagnostic test kit used in the detection of antibodies to HIV-1 present in urine | Calypte Biomedical Corp 1440 Fourth Street, Berkeley, CA 94701 License 1207 |
8/6/1996 |
| Antihemophilic Factor (Human) | Treatment of patients with hemophilia A | Centeon Pharma GmbH Post Office Box 1230 D-35002 Marburg GERMANY License 1202 |
8/22/1996 |
| Plasma | Transfusion | Am-Rho Laboratories,Inc 780 N. Park Blvd Suite 100 Clarkston, GA 30021 License 0991 |
8/22/1996 |
| Therapeutic Exchange Plasma | Collection of plasma from patients diagnosed with Guillain-Barre and who have developed high titers of IgM antibody to Cytomegalovirus | Community Blood Center of Greater Kansas City 4040 Main Street Kansas City, MO 64111 License 0302 |
9/3/1996 |
| Whole Blood | Transfusion | Sitka Community Hospital 209 Moller Street Sitka, AK 99835 License 1210 |
9/3/1996 |
| RSV High Titer Fraction II+III Paste (For Further Manufacturing Use) | Shared manufacturing arrangement with Massachusetts Public Health Biologic Labs | Baxter Heathcare Corp 305 South Street Boston, MA 02130 License 0140 |
9/10/1996 |
| COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine |
Immunization of persons 6 weeks to 15 months of age born of Hepatitis B Surface Antigen (HBsAg) negative mothers | Merck & Co, Inc Sumneytown Pike West Point, PA 19486 License 0002 |
10/2/1996 |
| Cryoprecipitated AHF | Control bleeding associated with Factor VIII deficiency | Blood Bank of the Redwoods 2324 Bethards Drive Santa Rosa, CA 95405-8537 License 0197 |
10/3/1996 |
| Whole Blood | Transfusion | South East Alaska Regional Health Consortium 222 Tongass Drive Sitka, AK 99835 License 1212 |
10/10/1996 |
| Whole Blood | Transfusion | Littleton Regional Hospital 107 Cottage Street Littleton, NH 03561 License 1213 |
10/10/1996 |
| Red Blood Cells | Transfusion | Littleton Regional Hosptial 107 Cottage Street Littleton, NH 03561 License 1213 |
10/10/1996 |
| Source Plasma | For Further Manufacture | Decatur Plasma, Inc 105 Chapel Drive Lafayette, LA 70506 License 1214 |
10/21/1996 |
| Source Plasma | For Further Manufacture | Atopix Pharma Corp 5375 Avenida Encinas Suite B Carlsbad, CA 92008 License 1215 |
10/21/1996 |
| Source Leukocytes | Transfusion | The Blood Center of New Jersey, Inc 45 South Grove St East Orange, NJ 07018 License 0221 |
11/13/1996 |
| Plasma | Transfusion | Puget Sound Blood Center 921 Terry Avenue Seattle, WA 98104 License 0192 |
11/21/1996 |
| Source Plasma | For further manufacture | Clinical Research Technologies 12095 W. Washington Boulevard Los Angeles, CA 90066 License 1217 |
12/11/1996 |
| UBI HIV 1/2 EIA Human Immuno-deficiency test to detect Virus Types 1 & 2 |
In vitro diagnostic antibodies to HIV 1/2 in human serum or plasma | United Biomedical, Inc 25 Davids Drive Hauppauge, NY 11788 License 1079 |
12/20/1996 |
| Cryoprecipitated AHF | Transfusion | Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226 |
12/26/1996 |
| Cryoprecipitated AHF | Transfusion | Blood Bank of San Bernardino and Pooled Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226 |
12/26/1996 |
| Source Plasma | For further manufacture | Cal Plasma Center, LLC 105 Chapel Drive Lafayette, LA 70506 License 1219 |
12/26/1996 |
| Cryoprecipitated AHF | Transfusion | Inova Health Care Services 3289 Woodburn Road, Suite 10 Annandale, VA 22003 License 0365 |
12/26/1996 |
| Source Plasma | For further manufacture | SeraCare, Inc 1925 Century Park East, Suite 1970 Los Angeles, CA 90067 License 1218 |
12/26/1996 |