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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2012 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
Action
STN
Manufacturer/
License No.
Approval Date
Fluarix Quadrivalent
Influenza Virus Vaccine
To include a quadrivalent influenza virus vaccine formulation for use in persons 3 years of age and older
 
125127/513GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
12/14/2012
Rotarix
Rotavirus Vaccine, Live, Oral
Package insert update to reflect the results from final analysis of the Mexico PASS study. 
 
125265/356GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
9/7/2012
Pentacel
Haemophilus b Conjugate
Vaccine (Tetanus Toxoid Conjugate) Reconstituted with
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Adsorbed Combined with Poliovirus Vaccine Inactivated
To include safety information regarding the risk of apnea in
premature infants to the
Warnings and Precautions section of the package insert.
125145/201Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4  Canada
License 1726
7/27/2012
Daptacel
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine
Adsorbed
To include safety information regarding the risk of apnea in premature infants to the Warnings and Precautions
section of the package insert.
103666/5277Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4  Canada
License 1726
7/27/2012
VAQTA
Hepatitis A Vaccine Inactivated 
To support concomitant administration of VAQTA® with Diptheria, Tetanus, acelluar Pertussis and Haemophilus influenzae type b vaccines in 12 to 23 months old children. 
 
103606/5469Merck Sharp & Dohme Corp.
P.O. Box 4
770 Sumneytown Pike
West Point, PA 19486
License 0002
7/18/2012
Gammagard Liquid
Immune Globulin Infusion (Human)
Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal
Motor Neuropathy (MMN). 
125105/961Baxter Healthcare Corporation
One Baxter Way
Westlake Village, CA  91362
License 0140
6/22/2012

Rotarix
Rotavirus Vaccine, Live, Oral 

To update the package insert and patient package insert to reflect transmission data from Twins Transmission Study Rota-052. 
 
125265/359GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
6/8/2012
Procleix Ultrio Plus Assay
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid
Pooled Testing/ Synthetic)
To include Procleix Ultrio Plus Assay, a qualitative in vitro nucleic acid assay system
intended to screen individual or pooled plasma and serum
specimens from human donors for human immunodeficiency
virus type I (HIV1) RNA, hepatitis C virus (HCV) RNA, and hepatitis B virus (HBV) DNA on the Procleix TIGRIS
System.
125113/48Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
License 1592
5/25/2012
BioThrax
Anthrax Vaccine Adsorbed
To change the dosing schedule from a five-dose primary schedule at 0, 1, 6, 12, 18 months with annual booster to a three dose primary schedule at 0, 1, 6 months, with boosters at 12 and 18 months after initiation of the primary series, and annual boosters thereafter.
 
103821/5203Emergent BioDefense
Operations Lansing LLC
3500 N. Martin Luther King, Jr., Blvd
Lansing, MI 48906
License 1755
5/17/2012
Xyntha
Antihemophilic Factor
(Recombinant), Plasma/Albumin
Free
Labeling revisions to demonstrate the safety and efficacy of Xyntha for surgical prophylaxis in patients with hemophilia A.
 
125264/797Wyeth
Pharmaceuticals Inc.
401 North Middletown Rd
Pear River, NY 10965
License 0003
4/12/2012
T.R.U.E. TEST Layer Rapid Use Epicutaneous TestTo add seven new allergens to the T.R.U.E. TEST103738/5074Mekos Laboratories AS
Herredsvejen 2
DK 3400 Hillerod
Denmark
License 1623
2/29/2012
Flumist Quadrivalent
Influenza Vaccine Live, Intranasal
To include a quadrivalent formulation containing two influenza A subtype viruses and two type B viruses.125020/1668MedImmune, LLC
One MedImmune Way
Gaithersburg, MD 20878
License 1799
2/29/2012
Adacel
Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular
Pertussis Vaccine, Adsorbed
To include geriatric use language in the label consistent with the geriatric labeling requirements, and to revise the content and format of the label according to current regulations.125111/304Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4  Canada
License 1726
2/16/2012
TISSEEL
Fibrin Sealant (Tisseel)
To support the indication
extension for general adjunct to hemostasis.
103980/5601Baxter Healthcare Corporation
One Baxter Way
Westlake Village, CA  91362
License 0140
1/25/2012
HepaGam B
Hepatitis B Immune Globulin
(Human)
Revision to the package insert to reflect the final clinical study data.125035/162Cangene Corporation
155 Innovation Dr.
Winnipeg,
R3T 5Y3 Manitoba,  Canada
License 1201
1/13/2012
HepaGam BT
Hepatitis B Immune Globulin
Intravenous (Human)
Revision to the package insert to reflect the final clinical study data.125237/125Cangene Corporation
155 Innovation Dr.
Winnipeg,
R3T 5Y3 Manitoba,  Canada
License 1201
1/13/2012
Cinryze
C1 Esterase Inhibitor(Human)
Incorporate additional safety data from the open-label uncontrolled routine prophylaxis trial protocol LEVP2006-4 ("Change 3" study) into the labeling.125267/312ViroPharma Biologics, Inc.
730 Stockton Drive
Extoh , PA 19341
License 1833
1/9/2012