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.

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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