• 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

2012 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

Tradename/
Proper Name
Indication for UseSTNManufacturer/
License Number
Approval Date
VariZIG
Varicella Zoster Immune Globulin (Human)
 
Post-exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella.
 
125430/0
 
Cangene Corp
155 Innovation Drive
Winnipeg, Manitoba
R3T 5Y3  Canada
License 1201
 
12/20/2012
 
Bivigam
Immune Globulin Intravenous (Human)
 

For the treatment of primary humoral immunodeficiency (PI) 

125389/0

Biotest Pharmaceuticals Corporation

5800 Park of Commerce Blvd., N.W.

Boca Raton, FL 33487

License 1792

12/19/2012
EVARREST
Absorbable Fibrin Sealant Patch
For use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.125392/0Ethicon, Inc.
G-106-10
P.O. Box 151, Route 22 West
Somerville, NJ 08876-0151
License 1879
 
12/5/2012
Flucelvax
Influenza Virus Vaccine
Active immunization of persons 18 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and B contained in
the vaccine.
125408/0Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Ave
Cambridge, MA 02139
License 1751
11/20/2012
DuCord
HPC, Cord Blood
For use in unrelated donor hematopoietic progenitor cell transplantation procedures in
conjunction with an appropriate
preparative regimen for
hematopoietic and immunologic
reconstitution in patients with disorders affecting the hematopoietic system that are
inherited, acquired, or result from myeloablative treatment.
125407/0Duke University School of Medicine
125 Davison Bldg
Durham, NC 27705
License 1870
10/4/2012
Blood Grouping Reagents:
Anti-K, Anti-Fya, Anti-Fyb, Anti-Wra, Anti-s
Multiple polyclonal in vitro diagnostic blood
grouping reagents.
125340/0
125341/0
125342/0
125343/0
125345/0
Alba Bioscience Limited
Ellen's Glen Rd
Edinburgh EH17 7QT
United Kingdom 
License 1807
9/27/2012
MENHIBRIX
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine 
 
Active immunization for the prevention of invasive diseases caused by Neisseria meningitides serogroups C and Y and Haemophilus influenzae type b in children 6 weeks through 18 months of age. 
 
125363/0GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
6/14/2012
HPC, Cord BloodFor use in unrelated donor hematopoietic progenitor cell
transplantation procedures in
conjunction with an appropriate
preparative regimen for
hematopoietic and immunologic
reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
 
125391/0Clinimmune Labs
12635 East Montview Blvd
Suite 300
Aurora, CO 80045
License 1855
5/24/2012
Avioq HTLV-I/II Microelisa System
Human T-Lymphotropic Virus
Types I & II (HTLV-I and HTLV-II/Enzyme Immuno
Assay (EIA)/Lysate)
For the detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus Type II (HTLV-II) in human serum or plasma. It is intended for screening individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II, and for use as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. In addition to being used as a manual assay, the assay is also intended for use with the ORTHO® Summit System (OSS) for screening blood donors.
 
125394/0AVIOQ, Inc.
104 T.W. Alexander Dr.
P.O. Box 12808
Research Triangle Park, NC 27709
License 1856
3/26/2012
GINTUIT
Allogeneic Cultured
Keratinocytes and Fibroblasts in
Bovine Collagen
For topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. GINTUIT is not intended to provide root coverage.
 
125400/0Organogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
License 1863
3/9/2012
ALBAcyte
Reagent Red Blood Cells  
Reagent Red Blood Cells Licensure of reverse grouping (A1, A2, B, O rr) , antibody screening, antibody identification (papain-treated, and untreated) in tube testing.125337/0Alba Bioscience Limited
Ellen's Glen Road
Edinburgh
EH17 7QT United Kingdom
License 1807
1/13/2012