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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2010 Biological License Application Supplement Noteworthy 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 by date of approval, with the most recent action at the top.


Tradename/
Proper Name
Indication for UseSTNManufacturer/
License No.
Approval Date
GARDASIL
Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
Prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine, in males and females 9 through 26 years of age, and the prevention of anal cancer caused by HPV types 16 and 18 in males and females 9 through 26 years of age125126/1895Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
12/22/2010
Agriflu
Influenza Vaccine
To include data from the confirmatory clinical studies to verify and describe the clinical benefit125297/1Novartis Vaccines and Diagnostics, Inc.
4560 Horton St
Emeryville, CA 94608-2916
License 1751
10/29/2010
Ixiaro
Japanese Encephalitis Virus Vaccine Inactivated
To include long term immuno-genicity data in the package insert and the use of a booster dose following the
primary series
125280/19Intercell AG
Campus Vienna Biocenter 2
1030 Vienna Austria
License 1790
10/14/2010
Gamunex
Immune Globulin Intravenous
(Human), 10%,
Caprylate/Chromatography
Purified (IGIV-C)
New route of administration: subcutaneous, for the treatment of Primary Humoral Immunodeficiency125046/619Talecris Biotherapeutics, Inc.
8368 U.S. 70 W
Clayton, NC 27520
License 1716
10/13/2010
AFLURIA
Influenza Virus Vaccine
2010-2011 United States
formulation
125254/181CSL Limited
45 Poplar Road
Parkville, Victoria
3052 Australia
License 1764
7/30/2010
FLUARIX
Influenza Virus Vaccine
2010-2011 United States
formulation
125127/432GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
7/28/2010
Agriflu
Influenza Vaccine
2010-2011 United States
formulation
125297/3Novartis Vaccines and Diagnostics, Inc.
4560 Horton St
Emeryville, CA 94608-2916
License 1751
7/28/2010
FluVirin
Influenza Virus Vaccine
2010-2011 United States
formulation
103837/5543Novartis Vaccines and Diagnostics Limited
Gaskill Road
Speke, Liverpool L24 9GR
License 1750
7/28/2010

Flebogamma
Immune Globulin Intravenous (Human)

 

Additional strength, 10% immunoglobulin concentration125077/146 

Instituto Grifols, S.A.
2 Can Guasch St.
Poligono Levante
Parets Del Valles
08150 Barcelona Spain
License 1181

7/27/2010
FluLaval
Influenza Virus Vaccine
2010-2011 United States
formulation
125163/172ID Biomedical Corporation of
Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739
7/23/2010
Fluzone
Influenza Virus Vaccine
2010-2011 United States
formulation
103914/5326Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370-0187
License 1725
7/23/2010
Flumist
Influenza Virus Vaccine Live, Intranasal
2010-2011 United States
formulation
125020/1436MedImmune, LLC
297 North Bernardo Ave
Mountain View, CA 94043
License 1799
7/22/2010
GARDASIL
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
 
For concomitant administration with Menactra® and ADACEL®125126/1516Merck & Co., Inc.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
6/9/2010
VAQTA
Hepatitis A Vaccine Inactivated
Concomitant administration with Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®) and pneumococcal conjugate vaccine (Prevnar®); A statement in Section 14.4 of the package insert on duration of immune response to extend the duration of immunity out to 10 years post-vaccination; and revisions to the labeling to comply with the Physicians Labeling Rule.103606/5374

Merck & Co., Inc.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002

 

3/30/2010

Pediarix
DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine

 

Update package insert to include results from a postmarketing safety surveillance study that evaluated the risk of all seizures (with or without fever), and the risk of medically attended fever following Pediarix® administration in a cohort of infants at a U.S. Health Maintenance Organization, and to comply with the labeling requirements of the Physicians Labeling Rule.103907/5227

GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617

 

3/5/2010
CroFab
Crotalidae Polyvalent Immune Fab (Ovine)

Treatment for severe envenomation.

 

103788/5144Protherics Inc. a wholly-owned
subsidiary of Protherics PLC,
c/o Therapeutic Antibodies, Inc.
5214 Maryland Way, Suite 405
Brentwood, TN 37027
License 1575
3/4/2010