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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2000 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 STN Manufacturer/
License Number
Approval Date
Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease   Lederle Laboratories Division
American Cyanamid Company
401 N. Middletown Road
Pearl River, NY 10965
License 0017
2/17/2000
ReFacto
Antihemophilic Factor (Recombinant)
Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A   Genetics Institute, Inc
One Burtt Road
Andiver, MA 01810-5901
License 1163
3/6/2000
PACIS
BCG, Live
Treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the bladder   BioChem Pharma Inc
2323 Parc Technologique Blvd
Sainte-Foy, Quebec
Canada
License 1283
3/9/2000
Plasma Transfusion   Rex Hospital, Inc
4420 Lake Boone Trail
Raleigh, NC
License 0748
3/10/2000
Platelets Transfusion   Rex Hospital, Inc
4420 Lake Boone Trail
Raleigh, NC
License 0748
3/10/2000
ID Micro Typing Systems
Anti-A (Murine Monoclonal)
In vitro test/antigen detection; monoclonal antibody, derived from the BIRMA-1 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd 103787/0 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177
9/21/2000
ID Micro Typing Systems
Anti-B (Murine Monoclonal)
In vitro test/antigen detection; monoclonal antibody, derived from the LB-2 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd 103789/0 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177
9/21/2000
ID Micro Typing Systems
Anti-A and B (Murine Monoclonal); Anti-A,B (Murine Monoclonal)
In vitro test/antigen detection; monoclonal antibody, derived from the ES-15 & ES-4 cell lines, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd 103790/0 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177
9/21/2000
ID Micro Typing Systems
Anti-D (Human Monoclonal) (IgM)
In vitro test/antigen detection; monoclonal antibody, derived from the MS-201 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd 103791/0 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177
9/21/2000
Crofab
Crotalidae Polyvalent Immune Fab (Ovine)
Treatment of minimal and moderate North American Crotalidae envenomation 103788/0 Protherics, Inc
(a wholly-owned subsidiary of Protherics PLC)
1207 17 th Avenue S, Suite 103
Nashville, TN 37212
License 1575
10/2/2000