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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2008 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.


Note: Approvals are listed with the most recent action at the top.

Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
COBAS TaqScreen MPX Test
Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay
For the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma. 125255/0 Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton , CA 94588-2722
License 1636
12/30/2008
Source Plasma New facility in Austin, Texas, FEI 3006605566 125275/0 DCI Biologicals Austin, LLC
5789 Airport Blvd.
Austin , TX 78752
License 1788
12/18/2008
Cinryze
C1 Esterase Inhibitor (Human)
For routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE). 125267/0 Lev Pharmaceuticals, Inc.
730 Stockton Drive
Exton , PA 19341
License 1780
10/10/2008
Source Plasma Acquisition of licensed centers for IBR PlasmaCenters, LLC from International BioResources, Inc. 125322/0 IBR PlasmaCenters, LLC
1200 Camellia Boulevard
Lafayette , LA 70508
License 1808
9/17/2008
Source Plasma New manufacturer in San Marcos, TX, FEI 3006521938. 125273/0 DCI Biologicals San Marcos, LLC
1400 IH 35 South
San Marcos , TX 78666
License 1784
9/3/2008
Anti-Human Globulin
(Murine Monoclonal)(For Further Manufacturing Use); anti-S (Monoclonal)(For Further Manufacturing Use)
For shipment to -----(b)(4)---. 125238/0
125239/0
Millipore ( UK) Ltd.
Fleming Road
Livingston UK EH54 7BN
License 1761
8/14/2008
Blood Grouping Reagents, Anti-s (Monoclonal)(IgG)(For Further Manufacturing Use); Anti-P1(Murine Monoclonal)(IgM)(For Further Manufacturing Use); Anti-Fya(Monoclonal)(IgG)(For Further Manufacturing Use); Anti-C(Human Monoclonal)(IgM)(For Further Manufacturing Use) For shipment to -----(b)(4)---. 125209/0
125210/0
125211/0
125236/0
Diagast
Parc Euransante
251, av. Eugene Avinee – BP9
Loos Cedex
France 59374
License 1744
8/14/2008
Seraclone
Blood Grouping Reagents and Anti-Human Globulin reagents
For the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test 125213/0
125217/0
125219/0
125220/0
125221/0
125222/0
125223/0
125224/0
125225/0
125226/0
125227/0
125228/0
125229/0
125230/0
125231/0
125232/0
125233/0
125215/0
125242/0
Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Biotestcell and Erytypecell
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems
Reagent Red Blood Cells are for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO® optimo automated blood grouping and antibody test system. 125207/0
125208/0
Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Erytype S
Blood Grouping Reagents
For use on the Erytype® S Rh + K Type plate for Rh and Kell typing on the TANGO® optimo automated blood grouping and antibody test system 125202/0
125203/0
125204/0
125205/0
125206/0
125218/0
Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Seraclone
Blood Grouping Reagent Anti-Fya (Monoclonal)
For the determination of the blood group antigens on red blood cells using the tube test 125212/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Seraclone
Blood Grouping Reagent Anti-s (Monoclonal)
For the determination of the blood group antigens on red blood cells using the tube test 125214/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
Seraclone
Blood Grouping Reagent Anti-S (Monoclonal)
For the determination of the blood group antigens on red blood cells using the tube test 125216/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798
8/14/2008
KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose 125260/0 GlaxoSmithKline Biologicals Rue de I'Institut 89
B1330 Rixensart, Belgium
License No. 1617
6/24/2008
Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday) 125145/0 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada
License No. 1726
6/20/2008
ROTARIX
Rotavirus Vaccine, Live, Oral
Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks 125265/0 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart, Belgium
License 1617
4/3/2008
ARTISS
Fibrin Sealant (Human)
To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations 125266/0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362-3811
License 0140
3/19/2008
XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A. 125264/0 Wyeth Pharmaceuticals, Inc
401 North Middletown Road
Pearl River, NY 10965
License 0003
2/21/2008
Red Blood Cells Licensure for CPD/AS-5 RBC and CPD/AS-5 Leukocytes-reduced RBC at St. Lukes Hospital Blood Bank, 1026 A Avenue, NE,Cedar Rapids, IA 52406-3026 (Registration Number 1970362). OTL Mississippi Valley Regional Blood Center U.S. Lic. 366; Reg. No. 3005754990; CLIA 16D038796. 125269/0 St. Luke's Hospital Blood Bank
1026 A Avenue, NE
Cedar Rapids, IA 52406-3026
License 1782
2/20/2008
RECOTHROM
Thrombin, topical (Recombinant)
An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical 125248 / 0 ZymoGenetics, Inc
1201 Eastlake Avenue East
Seattle, WA 98102
License 1758
1/17/2008
ABBOTT PRISM HTLV-I/HTLV-II
Human T-Lymphotropic Virus Types I and II
To be used as a screening test for 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. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating. 103761 / 0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Road
Chicago, IL 60064
License 0043
1/16/2008
OLYMPUS PK System Blood Grouping and Phenotyping Reagents For the in vitro detection and identification of human blood group antigens by direct agglutination 125169/0
125170/0
125171/0
125172/0
125173/0
125174/0
125175/0
125176/0
125177/0
125186/0
125168/0
DIAGAST
251 avenue Eugène Avinée - BP 9
59374 Loos Cedex
FRANCE
License 1744
1/10/2008