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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2008 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 by date of approval, with the most recent action at the top.


Tradename/
Proper Name
Indication for Use STN Manufacturer/
License No.
Approval Date
BioThrax
Anthrax Vaccine Adsorbed
Change in schedule and route administration 103821/5080 Emergent BioDefense Operations Lansing, Inc. 3500 N. Martin Luther King, Jr., Blvd.
Lansing , MI 48906
License 1755
12/11/2008
Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Booster immunization against diphtheria, tetanus, and pertussis in healthy individuals 19 - 64 years of age 125106/298 Glaxo SmithKline Biologicals
Rue de I’Institut 89
B1330 Rixensart
Belgium
License 1617
12/4/2008
Kogenate FS
Antihemophilic Factor (Recombinant)
Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. 103332/5794 Bayer HealthCare LLC
800 Dwight Way, P.O. Box 1986
Berkeley , CA 94701
License 0008
10/10/2008
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Prevention of vulvar and vaginal cancer 125126/419 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point , PA 19486
License #0002
9/12/2008
Gamunex
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse 125046/409 Talecris Biotherapeutics, Inc.
8368 US Hwy 70 West
Clayton , NC 27520
License #1716
9/12/2008
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Includes pertussis immune response data from the Rotavirus Efficacy and Safety Trial (REST) to support concomitant use of DTaP with RotaTeq®. 125122/368 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point , PA 19486
License 0002
9/5/2008
Blood Grouping Reagent: Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing); Anti-Human Globulin (Formulated for Automated Testing) Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system. 125097/10
125098/8
Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Procleix Ultrio Assay
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic)
Labeling Changes 125113/19 Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
License 1592
8/12/2008
Pneumovax 23
Pneumococcal Vaccine, Polyvalent
Labeling Change: To include the new term “Leukocytosis” in the Adverse Reactions section of the package insert 101094/5245 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
8/6/2008
Fluarix
Influenza Virus Vaccine
2008-2009 United States Formulation 125127/294 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
License #1617
8/4/2008
Fluvirin
Influenza Virus Vaccine
2008-2009 United States Formulation 103837/5358 Novartis Vaccines and Diagnostics Limited
Gaskill Road
Liverpool L24 9GR
United Kingdom
License #1750
8/1/2008
Afluria
Influenza Virus Vaccine
2008-2009 United States Formulation 125254/74 CSL Limited
1020 First Avenue
P.O. Box 60446
King of Prussia, PA 19406-0446
License No. 1764
7/30/2008
FluLaval
Influenza Virus Vaccine
2008-2009 United States Formulation 125163/79 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739
7/28/2008
FluMist
Influenza Virus Vaccine Live, Intranasal
2008-2009 United States Formulation 125020/794 MedImmune Vaccines, Inc
297 North Bernardo Avenue
Mountain View CA 94043
License 1652
7/25/2008
Fluzone
Influenza Virus Vaccine
Revisions to the Package Insert:
To Comply with Physician's Labeling Rule Guidelines
103914/5157 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725
7/14/2008
Fluzone
Influenza Virus Vaccine
2008-2009 United States Formulation 103914/5204 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725
7/14/2008
FluMist
Influenza Virus Vaccine Live , Intranasal
To include labeling revisions for the 2008-2009 influenza season 125020/716 MedImmune Vaccines, Inc
297 North Bernardo Avenue
Mountain View CA 94043
License 1652
7/3/2008
GARDASIL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
To include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert 125126/758 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
6/12/2008
TENIVAC
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Use in adults 60 years of age and older for active immunization for the prevention of tetanus and diphtheria 103171/5045 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726
6/5/2008
FluLaval
Influenza Virus Vaccine
Update the language in the package insert to be consistent with new content and format labeling requirements 125163/48 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739
5/16/2008
M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live
To include epididymitis under Urogenital System in the adverse reactions section of the package insert to reflect reports received during post-marketing surveillance, and to include additional minor editorial changes 101069/5172 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
5/16/2008
NovoSevenRT
Coagulation Factor VIIa (Recombinant)
Room temperature stable formulation 103665/5231 Novo Nordisk Inc
100 College Rd West
Princeton, NJ 08540
License #1261
5/9/2008
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq 125122/443 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
4/30/2008
cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
To include testing for West Nile Virus RNA in post mortem cadaveric (non-heart-beating) donors using an individual testing format 125245/17 Roche Molecular Systems, Inc,
4300 Hacienda Drive
Pleasanton, CA
94588-2722
License 1636
4/2/2008
 Havrix
Hepatitis A Vaccine, Inactivated
To include coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar®) with Hepatitis A Vaccine Inactivated (Havrix®) for children in the second year of life 103475/5195 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart, Belgium
License 1617
3/26/2008
ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed
To include unit dose syringes as an alternate presentation 125111/102 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726
3/18/2008
DAPTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
To include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL 103666/5158 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726
3/12/2008
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Revisions to the package insert 125108/266 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
2/27/2008
YF-Vax
Yellow Fever Vaccine
Changes to the package insert 103915/5086 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725
2/12/2008
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Changes to the package insert 125126/578 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
1/9/2008
EVICEL
Fibrin Sealant (Human)
Use in general surgery 125010/105 Omrix biopharmaceuticals Ltd.
200 Chaussee De Waterloo
1640 Rhode-St-Genese
Belgium
License 1603
1/2/2008