2004 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.
Transfer of Therapeutic Products to CDER
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Fluzone Influenza Virus Vaccine |
New Dosage Form: Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes |
103914 / 5082 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
12/23/2004 |
| Dryvax Smallpox Vaccine, Dried, Calf Lymph Type |
Package Insert Revision: Include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults |
101106 / 5057 | Wyeth Pharmaceuticals, Inc 401 N. Middletown Rd Pearl River, NY 10965 License 0003 |
11/5/2004 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
New Storage Conditions: Storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox" |
125020 / 43 | MedImmune Vaccines, Inc One MedImmune Way Gaithersburg, MD 20878 License 1652 |
11/2/2004 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
New formulation: 2004-2005 United States Formulation |
125020 / 33 | MedImmune Vaccines, Inc 297 N. Bernardo Ave Mountain View, CA 94043 License 1652 |
9/15/2004 |
| HIVAB HIV-1 / HIV-2 (rDNA) EIA Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA)/Recombinant) |
Labeling Change: Include cadaveric serum specimen testing |
103385 / 5004 | Abbott Laboratories D-049C/AP6C/2 100 Abbott Park Road Abbott Park, IL 60064-3500 License 0043 |
7/22/2004 |
| Abbott HCV EIA 2.0 Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) |
Labeling Change: Include cadaveric serum specimen testing |
103356 / 5000 | Abbott Laboratories D-049C/AP6C/2 100 Abbott Park Road Abbott Park, IL 60064-3500 License 0043 |
7/22/2004 |
| Fluzone Influenza Virus Vaccine |
New formulation: 2004-2005 United States Formulation |
103914 / 5077 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
7/2/2004 |
| FluVirin Influenza Virus Vaccine |
New formulation: 2004-2005 United States Formulation |
103837 / 5053 | Evans Vaccines, Ltd Gaskill Road Speke, Liverpool L24 9GR United Kingdom License 1615 |
7/2/2004 |
| Procleix Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) |
Expanded indication for use: Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing; and testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors) |
103966 / 5021 | Gen-Probe, Inc 10210 Genetic Center Drive San Diego, California 92121-1589 License 1592 |
6/4/2004 |
| COBAS Ampliscreen HCV Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) |
Expanded indication for use: Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) |
125045 / 5011 | Roche Molecular Systems 4300 Hacienda Drive PO Box 9002 Pleasanton, CA 94566-0900 License 1636 |
5/13/2004 |
| Biothrax Anthrax Vaccine Adsorbed |
Extension of dating to 24 months | 103821 / 5051 | BioPort Corp 3500 N. Martin Luther King Jr Blvd Lansing, MI 48906 License 1260 |
4/29/2004 |
|
DECAVAC Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use |
New Dosage Form: Addition of a preservative-free, single dose Luer-Lok syringe presentation |
103921 / 5031 | Aventis Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1277 |
3/24/2004 |
| Carticel Autologous Cultured Chondrocytes |
Processing Change: To utilize the BacT/Alert automated microbial detection system for the release of Carticel product based on interim negative results at approximately day 3 of a 14-day assay |
103661 / 5019 | Genzyme Biosurgery 55 Cambridge Parkway Cambridge, MA 02142 License 1659 |
2/17/2004 |