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Vaccines, Blood & Biologics

2011 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.


2011 Biological License Application Supplement Approvals
Tradename/
Proper Name
Action STN Manufacturer/
License No.
Approval Date
Prevnar 13
Pneumococcal 13-valent
Conjugate Vaccine (Diphtheria CRM197 Protein)
 
Include the prevention of pneumonia and invasive disease caused by S.  pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older.
125324/262 Wyeth Pharmaceuticals, Inc.
401 N. Middletown Rd
Pearl River, NY 10965
License 0003
12/30/2011
Berinert
C1 Esterase Inhibitor (Human)
To include treatment of acute abdominal, facial, or laryngeal attacks of Hereditary Angioedema (HAE) in adult and adolescent patients and to submit the PMR Final Study Report under 505(o) - Completion of
Planned Ongoing Open Label
Extension Study CE1145_3003
(IMPACT II) for laryngeal HAE attacks.
125287/110
 
CSL Behring GmbH
1020 First Avenue
King of Prussia, PA 19406-0901
License 1765
12/22/2011
Advate
Antihemophilic Factor
(Recombinant), Plasma/Albumin
Free Method
 

New indication: for routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with Hemophilia A.

125063/822 Baxter Healthcare Corporation
One Baxter Way
Westlake Village, CA  91362
License 0140
12/14/2011
Afluria
Influenza Virus Vaccine   
Final Post Marketing
Commitment Study Reports
covering PMCs 1 and 2 under
STN 125254/0 and 1 and 2 under STN 125254/132. 
125254/259  CSL Limited
45 Poplar Road
Parkville, Victoria 3052  Australia
License 1764 
12/2/2011
Menactra
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide
Diphtheria Toxoid Conjugate Vaccine
Data to update the package insert with results from a retrospective study to assess the risk of Guillain-Barre Syndrome (GBS) following administration of Menactra.  125089/424  Sanofi Pasteur Inc.
Discovery Dr
Swiftwater, PA 18370-0187
License 1725 
12/1/2011
ABBOTT ESA Chagas
Trypanosoma cruzi (E. coli, Recombinant)  
In vitro enzyme strip assay
intended for the qualitative
detection of antibodies to
Trypanosoma cruzi (T cruzi) in
human serum and plasma
specimens; intended for use as
an additional, more specific test
on human serum or plasma
specimens found to be repeatedly reactive using a licensed screening test for antibodies to T cruzi. 
125361/23 Abbott Laboratories
100 Abbott Park Rd
Abbott Park, IL 60064
License 0043 
11/18/2011
Pneumovax 23
Pneumococcal Vaccine,
Polyvalent
Allow the addition of
information regarding
concomitant administration with
ZOSTAVAX® to the labeling and revise the labeling to comply with the Physician’s Labeling Rule (PLR).
101094/5324 Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
10/27/2011
Hizentra
Immune Globulin Subcutaneous
(Human), 20% Liquid
Inclusion of efficacy and safety data from European Study ZLB06_001CR into the package insert.  125350/136 CSL Behring AG
Wankdorfstrasse 10
3000 Berne 22
Switzerland
License 1766
10/3/2011
ARTISS
Fibrin Sealant (Human) 
Extend the indication to adhere tissue flaps during facial
rhytidectomy surgery (face-lift).
125266/194 Baxter Healthcare Corporation
One Baxter Way
Westlake Village, CA 91362
License 0140
8/29/2011
Havrix
Hepatitis A Vaccine Inactivated
Clinical data to support the coadministration with M-M-RII
and VARIVAX and to fulfill PMCs 1 and 3 under STN 103475/5090.
103475/5343 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
7/22/2011
Gammagard Liquid
Immune Globulin Infusion (Human)
Treatment of primary immunodeficiency disorders (PID) associated with defects in
humoral immunity by
subcutaneous route of administration. 
125105/708 Baxter Healthcare Corporation
One Baxter Way
Westlake Village, CA  91362
License 0140
7/22/2011
Cervarix
Human Papillomavirus Bivalent
(Types 16 and 18) Vaccine, Recombinant 
Safety and immunogenicity data
to support use in females as young as 9 years of age. 
125259/132 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
7/19/2011
 
Pentacel Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated Changes to the package insert regarding the dosage and administration claim. 125145/150 Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 7/15/2011
Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Package insert revisions to update the safety data on use of a fifth dose of DAPTACEL® in children four through six years of age who received four doses of PENTACEL®. 103666/5254 Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726

7/15/2011

Afluria
Influenza Virus Vaccine 
2011-2012 United States formulation and to revise the age indication from 6 months and older to 5 years and older. 125254/303 CSL Limited
45 Poplar Rd
Parkville, Victoria  Australia 3052
License 1764
7/15/2011
BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed To include immunogenicity and safety data to support the use of Boostrix® in individuals 65 years of age and older. 125106/680 GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 7/8/2011
FluLaval
Influenza Virus Vaccine
2011-2012 United States formulation 125163/204 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec
87V 3S8  Canada
License 1739
6/30/2011
Fluarix
Influenza Virus Vaccine
2011-2012 United States formulation 125127/472 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
6/30/2011
FluMist
Influenza Virus Vaccine Live, Intranasal 
2011-2012 United States formulation 125020/1670 MedImmune, LLC
One MedImmune Way
Gaithersburg, MD 20878
License 1799
6/30/2011
 
Fluvirin
Influenza Virus Vaccine
2011-2012 United States formulation 103837/5571 Novartis Vaccines and
Diagnostics Limited
Gaskill Rd
Speke, Liverpool
L24 9GR
License 1750
6/30/2011
 
Fluzone
Influenza Virus Vaccine 
2011-2012 United States formulation 103914/5449 Sanofi Pasteur Inc.
Discovery Dr
Swiftwater, PA 18370-0187
License 1725
6/27/2011
FluLavalInfluenza Virus Vaccine To include data in the prescribing information from a clinical endpoint study and a non-inferiority immunogenicity study conducted in adults.

125163/176

ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739

6/9/2011

FluMist
Influenza Vaccine Live, Intranasal
 
Package insert revisions to include data from clinical trials characterizing vaccine virus shedding in healthy subjects and from small studies of immuno- compromised subjects after administration of FluMist
 
125020/1465 MedImmune, LLC
One MedImmune Way
Gaithersburg, MD 20878
License 1799
 
5/26/2011
Fluzone
Influenza Virus Vaccine
 
Active immunization of persons 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the
vaccine; New ro ute of admin: Intradermal.
 
103914/5369 Sanofi Pasteur Inc.
Discovery Dr
Swiftwater, PA 18370-0187
License 1725
 
5/9/2011
Menactra
Meningococcal Groups (A, C, Y,
and W-135) Polysaccharide
Diphtheria Toxoid Conjugate
Vaccine
 
Safety and immunogenicity data
to support use in children 9 through 23 months of age to
prevent invasive meningococcal
disease caused by N. meningitidis serogroups A, C, Y,
and W-135.
 
125089/395 Sanofi Pasteur Inc.
Discovery Dr
Swiftwater, PA 18370-0187
License 1725
 
4/22/2011
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
Package insert revisions regarding results of a post marketing safety study (Study 019) 125122/685  Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
4/8/2011
GARDASIL
Human Papillomavirus
Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
To include information in the "Limitations of Use" section of the prescribing information that Gardasil does not prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. Information on studies in women 27 through 45 years of age is also included. 125126/773 Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
4/5/2011
Menveo
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide
Diphtheria CRM197 Conjugate Vaccine 
Revisions to the package insert to include the re-evaluated
immunogenicity data due to a
transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission
(125300/0). 
125300/7 Novartis Vaccines and
Diagnostics, Inc.
4560 Horton Street
Emeryville, CA 94608-2916
License 1751
4/1/2011
Menveo
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide
Diphtheria CRM197 Conjugate Vaccine 
Revisions to the package insert to include the re-evaluated
immunogenicity data due to a
transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission
(125300/0).
125300/49 Novartis Vaccines and
Diagnostics, Inc.
4560 Horton Street
Emeryville, CA 94608-2916
License 1751
4/1/2011
Zostavax
Zoster Vaccine Live
Prevention of herpes zoster (shingles) in individuals 50-59
years of age and older.
125123/734 Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
3/24/2011
Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular
Pertussis Vaccine, Adsorbed
Revised package insert in the PLR format that includes clinical data describing the concomitant
use of Boostrix and Menactra (Fulfilling PMC #1 from STN
125106/386)
125106/628 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
3/17/2011
DECAVAC
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Package insert revisions to include additional safety and immunogenicity data from the DECAVAC group of study Td506.  103921/5143 Sanofi Pasteur, Inc.
Discovery Dr
Swiftwater, PA 18370-0187
License 1725
3/7/2011
Menveo
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
To include safety and immunogenicity data to support use in children 2 through 10 years of age. 125300/95 Novartis Vaccines and Diagnostics, Inc.
4560 Horton St. Emeryville, CA 94608-2916
License 1751
 
1/28/2011

 

 

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