• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

2009 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
Fluzone High Dose
Influenza Virus Vaccine
Include high dose formulation of Fluzone for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine103914/5240Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370-0187
License 1725
12/23/2009
Zostavax
Zoster Vaccine Live
Changes to the Highlights, the Drug Interactions and the Clinical Studies sections of the package insert. The revised package insert includes the statement: ZOSTAVAX and PNEUMOVAX® 23 should not be given concurrently because concomitant use resulted in reduced immunogenicity of ZOSTAVAX125123/430Merck & Co., Inc.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
12/18/2009
Cobas TaqScreen MPX Test
HIV-1 Group O and M,HIV-2, HCV, and/or HBV (HIV-1/HIV-2/HCV/HBV/PCR/Blood cell Derived)
Testing of samples from source plasma donors in pools comprised of aliquots of 96 individual donations125255/3Roche Molecular Systems, Inc
4300 Hacienda Dr
Pleasanton, CA 94588-2722
License 1636
11/20/2009
Afluria
Influenza Virus Vaccine
Active immunization against influenza for individuals 6 months through age 17 and to include the data from pediatric clinical studies with revision of the prescribing information for Afluria®. Under this approval,is a new presentation of 0.25 ml dose prefilled syringes125254/132CSL Limited
45 Poplar Road
Parkville, Victoria
Australia
License 1764
11/10/2009
Influenza Virus VaccineInfluenza A (H1N1) 2009 Monovalent Vaccine125163/135ID Biomedical
Corporation of Quebec
525 Cartier Blvd. West
Laval, Quebec
Canada
License 1739
11/10/2009
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in children 15 months to 12 years of age if a second dose of measles, mumps, rubella, and varicella is needed, additional safety data after a first or second dose of ProQuad®, and to comply with the Physician’s Labeling Rule format125108/341Merck & Co., Inc.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
License 0002
10/29/2009
FLUARIX
Influenza Virus Vaccine
Expanded indication for active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information for Fluarix®125127/319GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
10/19/2009
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Prevention of genital warts caused by HPV 6 and 11 in boys and men 9 through 26 years of age125126/1297Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002
10/16/2009
Prolastin-C
Alpha-1-Proteinase
Inhibitor (Human)
New version of product due to major modifications to the manufacturing process103174/5520Talecris Biotherapeutics, Inc.
368 U.S. 70 W
Clayton, NC 27520
License 1716
10/16/2009
FLUARIX
Influenza Virus Vaccine
Inclusion of adult efficacy data and adult non-inferiority data to the Prescribing Information125127/292GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
10/2/2009
Havrix
Hepatitis A Vaccine Inactivated
Coadministration with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix) and Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (ActHIB)103475/5284GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
10/1/2009
Influenza A (H1N1) 2009 MonovalentActive immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.125254/127CSL Limited
45 Poplar Rd
Parkville, Victoria Austrailia
License 1764
9/15/2009
Influenza A (H1N1) 2009 MonovalentActive immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus.125020/1215MedImmune LLC
297 North Bernardo Ave
Mountain View, CA 94043
License 1799
9/15/2009
Influenza A (H1N1) 2009 MonovalentActive immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.103837/5514Novartis Vaccines and Diagnostics Limited
Gaskill Road
Speke, Liverpool, L24 9GR
License 1750
9/15/2009
Influenza A (H1N1) 2009 MonovalentActive immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.103914/5260Sanofi Pasteur, Inc
Discovery Dr
Swiftwater, PA 18370-0187
License 1725
9/15/2009
Rotarix
Rotavirus Vaccine, Live, Oral,
To update the Prescribing Information125265/126GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
 
5/1/2009
Fluarix
Influenza Virus Vaccine
To include a thimerosal-free formulation in single-dose prefilled syringes and related changes in the labeling.125127/314GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617
 
4/1/2009
Infanrix
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Revisions to the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX and updated safety and immunogenicity data on the concomitant administration of INFANRIX with other recommended vaccines103647/5196GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617
3/12/2009
ORTHO T. cruzi ELISA Test System
Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen
Revise the package insert to include adding cadaveric specimens under the Intended Use section and changes to the Specimen Collection and Preparation section by adding Serum Separator Tube (SST) samples, elevated total protein, HAMA, and heterophilic antibodies specimens, as well as the addition of a new 192 test kit configuration.125161/23Ortho-Clinical Diagnostics, Inc.
1001 US Highway 202
Raritan , NJ 08869
License 1236
2/18/2009
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
To update the Patient Product Information and Prescribing Information.125122/524Merck & Co., Inc.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
License 0002
2/5/2009
ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed
To revise the package insert to include revision of the placement of information regarding latex
content of the product.
125111/193Sanofi Pasteur, Limited
1755 Steeles Avenue West
Toronto , Ontario Canada
License 1726
1/16/2009