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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2004 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
Fluzone
Influenza Virus Vaccine
New Dosage Form:
Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes
103914/5082 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
12/23/2004
Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type
Package Insert Revision:
Include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults
101106/5057 Wyeth Pharmaceuticals, Inc
401 N. Middletown Rd
Pearl River, NY 10965
License 0003
11/5/2004
FluMist
Influenza Virus Vaccine Live, Intranasal
New Storage Conditions:
Storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox"
125020/43 MedImmune Vaccines, Inc
One MedImmune Way
Gaithersburg, MD 20878
License 1652
11/2/2004
FluMist
Influenza Virus Vaccine Live, Intranasal
New formulation:
2004-2005 United States Formulation
125020/33 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652
9/15/2004
HIVAB HIV-1 / HIV-2 (rDNA) EIA
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA)/Recombinant)
Labeling Change:
Include cadaveric serum specimen testing
103385/5004 Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500
License 0043
7/22/2004
Abbott HCV EIA 2.0
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant)
Labeling Change:
Include cadaveric serum specimen testing
103356/5000 Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500
License 0043
7/22/2004
Fluzone
Influenza Virus Vaccine
New formulation:
2004-2005 United States Formulation
103914/5077 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
7/2/2004
FluVirin
Influenza Virus Vaccine
New formulation:
2004-2005 United States Formulation
103837/5053 Evans Vaccines, Ltd
Gaskill Road
Speke, Liverpool L24 9GR
United Kingdom
License 1615
7/2/2004
Procleix
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic)
Expanded indication for use:
Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing; and testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors)
103966/5021 Gen-Probe, Inc
10210 Genetic Center Drive
San Diego, California 92121-1589
License 1592
6/4/2004
COBAS Ampliscreen HCV
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)
Expanded indication for use:
Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
125045/5011 Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636
5/13/2004
Biothrax
Anthrax Vaccine Adsorbed
Extension of dating to 24 months 103821/5051 BioPort Corp
3500 N. Martin Luther King Jr Blvd
Lansing, MI 48906
License 1260
4/29/2004
DECAVAC
Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use
New Dosage Form:
Addition of a preservative-free, single dose Luer-Lok syringe presentation
103921/5031 Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1277
3/24/2004
Carticel
Autologous Cultured Chondrocytes
Processing Change:
To utilize the BacT/Alert automated microbial detection system for the release of Carticel product based on interim negative results at approximately day 3 of a 14-day assay
103661/5019 Genzyme Biosurgery
55 Cambridge Parkway
Cambridge, MA 02142
License 1659
2/17/2004