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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2013 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

TRETTEN
Coagulation Factor XIII A Subunit (Recombinant)

Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency
 

125398/0

Novo Nordisk Inc.
100 College Rd West
Princeton, NJ 

Lic# 1261

12/23/13

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
 

Active immunization for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
 

125419/0

ID Biomedical Corporation of Quebec
2323 Technology Park Boulevard
Sainte-Foy
Quebec, Canada

Lic# 1739
 

11/22/2013

Novoeight
Antihemophilic Factor (Recombinant)

Indicated for use in adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
 

125466/0

Novo Nordisk Inc.
100 College Rd West, Princeton NJ  08540

Lic# 1261

10/15/2013

Source Plasma
Multiple common human blood
products
 

Collection of Source Plasma from normal donors for the further manufacture of injectables at 1068 Broadway, El Cajon, California using the Haemonetics PCS-2 device, a physician substitute program and a computer assisted donor questionnaire. Relabeling of inadvertently collected
unacceptable units for the further manufacture of non-injectables.
 

125414/0
 

Scantibodies Biologics, Inc
El Cajon, CA  92021
Lic# 1874
 

8/14/2013
 

Thrombin (Recombinant) (For Further Manufacturing Use)
 
recombinant thrombin bulk drug substance for further manufacture
 
125458/0
 
ZymoGenetics, Inc
1201 Eastlake Ave East Seattle, WA 
98102
Lic# 1758
8/14/2013
Blood Grouping Reagents:
Anti-Human Globulin,
Anti-A, Anti-B, Anti-C, Anti-D, Anti-E, Anti-c, Anti-e, Anti-A,B and Anti-K,
Combination Kit,
Anti-Human Globulin, Combination Kit

 
Blood Grouping Reagent and Anti-Human Globulin Combination Kit for DG Gel 8 T/S Mono
 
125445/0
125449/0
125450/0
125451/0
125452/0
125453/0
125454/0
125455/0
125456/0
125457/0
125470/0
125474/0
 

Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Barcelona
Parets Del Valles, SP

Lic# 1887

7/19/2013
Blood Grouping Reagent, Anti-B (Murine Monoclonal) (For Further Manufacturing Use)(FFMU)
 
This and other Blood Grouping Reagents (For Further Manufacturing Use) listed in the approval letter are indicated for use in the manufacture of Blood Grouping Reagents, Anti-B, Anti-D and Anti-E by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, to produce in vitro product Blood Grouping Reagents (BGR) under a shared manufacturing arrangement.
 
125435/0
 

DIAGAST
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Lic# 1744
 

7/19/2013
 
Blood Grouping Reagent, Anti-A (Murine Monoclonal)(For Further Manufacturing Use)
 
For the in vitro detection and identification of human A and c blood group by column agglutination technology.
 
125438/0
125440/0
 
Alba Bioscience Limited
 
7/19/2013
 
Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Furthering Manufacturing Use) (FFMU)
 
Indicated for use in the production of DG Gel® 8 Anti-IgG (Rabbit) and DG Gel ® 8 T/S Mono gel cards
 
125439/0
 

DIAGAST
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Lic# 1744

7/19/2013
 
Blood Grouping Reagent, Anti-D (Human Monoclonal) (For Further Manufacturing) (FFMU)
 
This and other Blood Grouping Reagents (For Further Manufacturing Use) listed in the approval letter are indicated for use in the manufacture of Blood Grouping Reagents, Anti-B, Anti-D and Anti-E by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, to produce in vitro product Blood Grouping Reagents (BGR) under a shared manufacturing arrangement.
 
125442/0
 

DIAGAST
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Lic# 1744

7/19/2013
Blood Grouping Reagent, Anti-E (Human Monoclonal) (FFMU)
 
This and other Blood Grouping Reagents (For Further Manufacturing Use) listed in the approval letter are indicated for use in the manufacture of Blood Grouping Reagents, Anti-B, Anti-D and Anti-E by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, to produce in vitro product Blood Grouping Reagents (BGR) under a shared manufacturing arrangement.
 
125443/0
 

DIAGAST
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Lic# 1744

7/19/2013
 
Rixubis
Coagulation Factor IX (Recombinant)
For adults with Hemophilia B for (1) control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
 
125446/0
 
Baxter Healthcare Corporation
One Baxter Way
Westlake Village
CA 91362
License 0140
6/26/2013
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.
125432/0LifeSouth Community Blood Centers, Inc.
4039 Newberry Road
Gainesville FL
32607
License 1647
 
6/13/2013
Allocord
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.
 
125413/0
 
SSM Cardinal Glennon
Children's Medical Center
1465 South Grand Blvd.
St. Louis MO
63104
License 1873
5/30/2013
Kcentra
Prothrombin Complex Concentrate (Human) 
 
For the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding. 
 
125421/0 CSL Behring GmbH
1020 First Avenue
King of Prussia
PA 19406-0901
License 1765
 
4/29/2013
BAT
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) –(Equine) 
 
Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G in adults and pediatric patients. 
 
125462/0 Cangene Corporation
155 Innovation Drive
Winnipeg, Manitoba
R3T 5Y3 Canada
License 1201 
3/22/2013
OCTAPLAS
Pooled Plasma (Human),
Solvent/Detergent Treated
 

Replacement of multiple coagulation factors in patients with acquired
deficiencies due to liver disease and in patients undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic
purpura (TTP).
 

125416/0

Octapharma Pharmazeutika
Produktionsges.m.b.H.
Oberlaaer Strasse 235
A-1100 Vienna
Austria
License 1646

1/17/2013
FluBlok
Influenza Vaccine
 
Active immunization of adults 18 years of age and older against influenza disease.
 
125285/0
 
Protein Sciences Corporation
1000 Research Pkwy
Meriden, CO
06450
License 1795
 
1/16/2013