Vaccines, Blood & Biologics
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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 Use | STN | Manufacturer/ 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. | 125392/0 | Ethicon, 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. | 125408/0 | Novartis 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. | 125407/0 | Duke 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. | 125363/0 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 6/14/2012 |
| 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. | 125391/0 | Clinimmune 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. | 125394/0 | AVIOQ, 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. | 125400/0 | Organogenesis, 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. | 125337/0 | Alba Bioscience Limited Ellen's Glen Road Edinburgh EH17 7QT United Kingdom License 1807 | 1/13/2012 |
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