• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

1998 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 Manufacturer/
License No.
Approval Date
Cambridge Biotech HIV-1 (Western Blot)
Human Immunodeficiency Virus Type 1 (Western Blot)
New Indication:
For urine specimen testing

Cambridge Biotech Corp
1500 E. Gude Drive
Rockville, MD 20850
License 1063

 

05/28/1998
Genetic Systems rLAV
Human Immunodeficiency Virus Type 1
New HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen Genetic Systems Corp
6565 185th Avenue, NE
Redmond, WA 98052-5039
License 0978
06/29/1998
Engerix-B
Hepatitis B Vaccine (Recombinant)
New/Expanded Indication:
For use in individuals (adults) with chronic Hepatitis C infection
SmithKline Beecham Biologicals
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
License 1090
07/07/1998
TICE BCG
BCG Live
Expanded Indication:
For intravesical instillation to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder
Organon Teknika Corporation
100 Akzo Avenue
Durham, NC 27712
License 0956
08/21/1998
Mycobax
BCG Vaccine
Expanded Indication:
For immunization against tuberculosis
Connaught Laboratories Ltd
1755 Steeles Avenue, West
North York, Ontario
Canada MR2 3T4
License 0073
10/09/1998
Genetic Systems HIV-1 Western Blot
Human Immunodeficiency Virus Type 1 (Western Blot)
New Indication:
New HIV-1 Western Blot assay intended for use with persons of unknown risk as more specific test on human serum, plasma, or dried blood specimens found to be repeatedly reactive using screening procedure
Genetic Systems Corporation
6565 185th Avenue NE
Redmond, WA 98052-5039
License 0978
11/23/1998
Cytomegalovirus Immune Globulin Intravenous (Human) New Indication:
Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver pancreas and heart
Massachusetts Public Health
Biologic Laboratories
305 South Street
Boston, MA 02130-3597
License 0064
12/04/1998