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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2006 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
M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live
Changes to the package insert 101069/5116 Merck & Co., Inc
P.O. Box 1000
North Wales, PA 19454-1099
License 0002
12/29/2006
Flebogamma 5% DIF
Immune Globulin Intravenous (Human)
Addition of a viral inactivation step, new manufacturing facility, and a 400mL fill size 125077/47 Instituto Grifols, S.A.
2 Can Guasch St
Poligono Levante
Parets del Valles
Barcelona, Spain 08150
License 1181
12/21/2006
Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Changes to the package insert 103905/5332 Wyeth Pharmaceuticals Inc.
401 North Middleton Rd
Pearl River , New York 10965
License 0003
11/22/2006
 HibTITER
Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)
Changes to the package insert 103578/5063 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River, NY 10965
License 0003
11/17/2006
Varivax
Varicella Virus Vaccine Live
Revised Package Insert 103552/5141 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002
11/9/2006
DAPTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Revised labeling 103666/5071 Sanofi Pasteur Ltd
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4 Canada
License 1726
11/8/2006
NovoSeven
Coagulation Factor VIIa (Recombinant)
Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia 103665/5119 Novo Nordisk A/S
Novo Nordisk Pharmaceuticals, Inc.
100 College Rd West
Princeton, NJ 08540
License 1261
10/13/2006
APTIMA HIV-1 RNA Qualitative Assay
Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)
Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. 103966/5040 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592
10/4/2006
Menactra
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Revised Package Insert 125089/104 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725
10/3/2006
Daptacel
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Manufacture of the Pertussis antigen component 103666/5069 Sanofi Pasteur, Ltd.
1755 Steeles Ave West
Toronto, Ontario Canada M2R3T4
License 1726
8/23/2006
Tisseel VH Kit
Fibrin Sealant (Tisseel)
To include the incorporation of a second, independent virus inactivation step (solvent/detergent treatment), modifications to the manufacturing process and manufacturing locations within the Vienna facilities and the introduction of a frozen liquid presentation of the product 103980/5121 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 0140
7/27/2006
Fluarix
Influenza Virus Vaccine
New Formulation:
2006-2007 United States formulation
125127/139 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
7/25/2006
Fluvirin
Influenza Virus Vaccine
Labeling revisions and 2006-2007 United States formulation 103837/5104 Chiron Vaccines Ltd
Gaskill Road Speke,
Liverpool, L24 9GR, UK
License 1720
7/21/2006
FluMist
Influenza Virus Vaccine Live, Intranasal
New Formulation:
2006-2007 United States formulation
125020/238 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652
7/21/2006
Varivax
Varicella Virus Vaccine Live
Revised Package Insert 103552/5124 Merck & Co., Inc
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486
License 0002
7/12/2006
Benefix
Coagulation Factor IX (Recombinant)
Revised Package Insert 103677/5261 Wyeth Pharmaceuticals
P.O. Box 8299
Philadelphia, PA 19101-8299
License 0003
7/11/2006
Fluzone
Influenza Virus Vaccine
Labeling revisions for the 2006-2007 influenza season 103914/5125 Sanofi Pasteur, Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725
7/10/2006
FluMist
Influenza Virus Vaccine Live, Intranasal
Labeling revisions for the 2006-2007 influenza season 125020/201 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652
6/15/2006
Pediarix
DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine
Revised package insert for a safety and immunogenicty of a three dose series of Pediarix when administered with other recommended US-licensed vaccines including Prevnar 103907/5034 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
4/4/2006
Havrix
Hepatitis A Vaccine Inactivated
Package insert labeling changes regarding geriatric use 103475/5100 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
2/21/2006
OCTAGAM
Immune Globulin Intravenous, Human 5%
Revised Package Insert
Include labeling changes to the "Warnings/Blood Glucose Testing" and "Precautions/Drug/Laboratory Test Interactions" sections of the package insert strengthening the warning of effects of maltose in the product
125062/57 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
A-1100
Vienna Austria License 1646
2/3/2006
Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Revised Package Insert 125111/2 Sanofi Pasteur Limited
1755 Steeles Ave West
Toronto, Ontario M2R 3T4
Canada
License 1726
1/23/2006