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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2007 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
Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
To include the addition of "crying" to the Adverse Reaction - Postmarketing Experience section of the package insert 103905/5495 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003
12/11/2007
 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live
Change in the labeled potency of the mumps component from no less than 20,000 TCID50 to no less than 12,500 TCID50 per dose at end of expiry 101069/5061 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
12/6/2007
 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Changes to the package insert 125122/314 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
11/28/2007
Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Changes to the package insert 103905/5470 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003
11/13/2007
Fluvirin
Influenza Virus Vaccine
Update package insert 103837/5108 Novartis Vaccines and Diagnostics Limited
Gaskill Road, Speke
Liverpool L24 9GR
United Kingdom
License 1750
11/9/2007
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Package insert revisions 125108/218 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
10/23/2007
Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human)
To include a change in the storage conditions (up to 25ÂșC) for the complete shelf life of 24 months 103960/5346 CSL Behring GmbH
1020 First Avenue
King of Prussia, PA 19406-0901
Licence 1765
10/19/2007
Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Expanded age indication for subjects 2-10 years of age 125089/2 Sanofi Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1725
10/18/2007
Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type
Labeling Supplement:
Include additional language regarding skin lesions at the smallpox vaccination site
101106/5089 Wyeth Pharmaceuticals, Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003
10/2/2007
Gardasil
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Changes to the package insert 125126/428 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
10/1/2007
 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Revised Labeling:
Include the addition of G9 P1A[8] Serotype case reduction in the "Clinical Studies" section of the package insert, and revisions of the label in the Physician's Labeling Rule format
125122/201 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
9/28/2007
 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live
Changes to the package insert 101069/5143 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
9/24/2007
FluMist
Influenza Virus Vaccine Live, Intranasal
Indication Revision:
For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
125020/322 MedImmune Vaccines, Inc
(a wholly owned subsidiary of MedImmune, Inc.)
297 North Bernardo Ave
Mountain View, CA 94043
License 1652
9/19/2007
 FluLaval
Influenza Virus Vaccine
New Formulation:
2007-2008 United States formulation
125163/39 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739
9/12/2007
 COBAS AmpliScreen HBV Test
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived)
Changes in the labeling, testing requirement, and an increase in reagent refrigerator cycles 125090/21 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002 Pleasanton, CA 94566-0990
License 1636
8/16/2007
Fluarix
Influenza Virus Vaccine
New Formulation:
2007-2008 United States formulation
125127/229 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617
7/24/2007
Fluvirin
Influenza Virus Vaccine
New Formulation:
2007-2008 United States formulation
103837/5240 Novartis Vaccines and Diagnostics Limited
Gaskill Road, Speke
Liverpool L24 9GR
United Kingdom
License 1750
7/24/2007
Fluzone
Influenza Virus Vaccine
New Formulation:
2007-2008 United States formulation
103914/5167 Sanofi Pasteur, Inc.
Discovery Drive
Swiftwater, PA 18370 License 1725
7/13/2007
Zostavax
Zoster Vaccine Live
To include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine 125123/90 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
7/6/2007
Carticel
Autologous Cultured Chondrocytes
Revised Package Insert:
To include safety and efficacy data from the Study of the Treatment of Articular Repair; and formatting and content changes in compliance with the Physician's Labeling Rule
103661/5155 Genzyme Biosurgery
55 Cambridge Parkway
Cambridge, MA 02142
License 1659
6/21/2007
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)
To add the Procleix TIGRIS System for use with the Procleix Ultrio Assay 125113/2 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592
5/23/2007
COBAS AmpliScreen HIV-1 Test, version 1.5
Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction)
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles 125059/37 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002
Pleasanton CA 94566-0990
License 1636
5/23/2007
COBAS AmpliScreen HCV Test
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles 125045/5034 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002
Pleasanton CA 94566-0990
License 1636
5/22/2007
RECOMBIVAX HB
Hepatitis B Vaccine (Recombinant)
Changes to the package insert 101066/5159 Merck & Co., Inc.
P.O. Box 4
West Point, PA 19486-0004
License 0002
5/15/2007
EVICEL
Fibrin Sealant (Human)
An adjunct to hemostasis for use in patients undergoing liver or vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical 125010/74 Omrix biopharmaceuticals Ltd.
113 SE 5th Street
Oak Island, NC 28465
License 1603
5/9/2007
VAQTA
Hepatitis A Vaccine, Inactivated
Changes to the package insert 103606/5209 Merck & Co., Inc
P.O. Box 4
West Point, PA 19486-0004
License 0002
5/8/2007
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Changes to the package insert 125108/170 Merck & Co., Inc
P.O. Box 4
West Point, PA 19486-0004
License 0002
5/8/2007
Aralast NP
Alpha-1-Proteinase Inhibitor (Human)
For further manufacture into Alpha-1-Proteinase Inhibitor (A1PI) 125039/263 Baxter Healthcare Corp
One Baxter Way
Westlake Village, California 91362
License 0140
5/4/2007
Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Additional Indication: For adult and pediatric patients with von Willebrand disease for the prevention of excessive bleeding pre and post surgery 103960/5243 CSL Behring GmbH.
1020 First Avenue
King of Prussia, PA 19406
License 1765
4/27/2007
GARDASIL
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Changes to the package insert 125126/159 Merck & Co., Inc.
P.O. Box 4
West Point, PA 19486-0004
License 0002
4/3/2007
Menactra
Meningococcal Groups (A, C, Y and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
To include a single dose syringe presentation 125089/3 Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725
3/30/2007
TWINRIX
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Revised Package Insert: For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose 103850/5162 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617
3/28/2007
Rhophylac
Rho(D) Immune Globulin Intravenous (Human)
Expanded indication: for the treatment of Rho(D) positive, non-splenectomized adult patients with chronic Immune Thrombocytopenia Purpura (ITP) 125070/149 ZLB Behring AG
1020 First Avenue
King of Prussia, PA 19406-0901
License 1710
3/26/2007
Pediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Labeling Changes 103907/5195 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617
3/16/2007
Procleix West Nile Virus (WNV) Assay
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Revised Labeling:
To perform the Procleix WNV Assay with the Procleix TIGRIS System
125121/17 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592
3/2/2007
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Revised Package Insert 125108/164 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA. 19486
License 0002
2/27/2007
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Changes to the Package Insert: Including cases of intussusception and hematochezia seen post-marketing 125122/219 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
2/12/2007
Alphanate
Antihemophilic Factor (Human)
For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. 102475/5002 Grifols Biologicals Inc
5555 Valley Boulevard
Los Angeles, CA 90032
License 1694
1/31/2007
MERUVAX II
Rubella Virus Vaccine Live
Revised Package Insert 101075/5074 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002
1/31/2007
ATTENUVAX
Measles Virus Vaccine Live
Revised Package Insert 101068/5080 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002
1/31/2007
Engerix-B
Hepatitis B Vaccine (Recombinant)
Thimerosal-free formulation 103239/5109 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617
1/30/2007
GARDASIL
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Revised Package Insert 125126/109 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002
1/30/2007
Pediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Revised Package Insert:
For a preservative free/thimerosal free formulation
103907/5148 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617
1/29/2007
TWINRIX
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Revised Package Insert 103850/5173 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617
1/19/2007
Tubersol
Tuberculin, Purified Protein Derivative
Revised Package Insert 103941/5044 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
CANADA
License 1726
1/8/2007
FluMist
Influenza Virus Vaccine Live, Intranasal
New Formulation:
Convert from the frozen formulation to a liquid formulation
125020/90 MedImmune Vaccines, Inc
(a wholly owned subsidiary of MedImmune, Inc.)
297 North Bernardo Ave
Mountain View, CA 94043
License 1652
1/5/2007