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.
- Complete List of Currently Licensed Products and Establishments
- Transfer of Therapeutic Products to CDER
Note: Approvals are listed with the most recent action at the top.
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| 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 |