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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2000 Biological License Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
Genetic Systems HIV-1 / HIV-2 Peptide EIA
Human Immunodeficiency Virus Type 1 and 2 (Synthetic Peptide)
Expanded Indication:
Testing of cadaveric serum samples
  Genetic Systems Corp
6565 185th Avenue NE
Redmond, WA 98052-5039
License 0978
2/9/2000
Carticel SM Service
Autologous Cultured Chondrocytes
Narrow the indication to second line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure   Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139-4136
License 1233
3/2/2000
Kogenate FS
Antihemophilic Factor (Recombinant)
New product formulation   Bayer Corp
800 Dwight Way
P.O.Box 1986
Berkeley, CA
License 0008
6/26/2000
Anti-D, Anti-A, Anti-B, Anti-A,B Monoclonal Antibodies First approval for monoclonal antibodies to be used in a gel card; for further manufacture in a shared agreement with Micro Typing Systems, Inc 103856/1001 Serologicals LTD
Fleming Road
Livingston, United Kingdom
License 1270
9/21/2000
ID Micro Typing Systems
A/B/D Monoclonal Grouping Combination Gel Card
First approval for production of a monoclonal grouping combination gel card 103756/1005 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177
9/27/2000