2008 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 by date of approval, with the most recent action at the top.
- Complete List of Currently Licensed Products and Establishments
- Transfer of Therapeutic Products to CDER
Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
---|---|---|---|---|
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant |
Prevention of vulvar and vaginal cancer | 125126/419 | Merck & Co., Inc. P.O. Box 1000 UG2D-68 North Wales, PA 19454-1099 License #0002 |
9/12/2008 |
Gamunex Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified |
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse | 125046/409 | Talecris Biotherapeutics, Inc. 8368 US Hwy 70 West Clayton , NC 27520 License #1716 |
9/12/2008 |
Blood Grouping Reagent: Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing); Anti-Human Globulin (Formulated for Automated Testing) | Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system. | 125097/10 125098/8 |
Biotest Medical Diagnostics GmbH Industriestrasse 1 D-63303 Dreieich GERMANY License 1798 |
8/14/2008 |
Procleix Ultrio Assay
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic) |
Labeling Changes | 125113/19 | Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121 License 1592 |
8/12/2008 |
Pneumovax 23 Pneumococcal Vaccine, Polyvalent |
Labeling Change: To include the new term “Leukocytosis” in the Adverse Reactions section of the package insert | 101094/5245 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
8/6/2008 |
Fluarix Influenza Virus Vaccine |
2008-2009 United States Formulation | 125127/294 | GlaxoSmithKline Biologicals 2301 Renaissance Boulevard P.O. Box 61540 King of Prussia, PA 19406-2772 License #1617 |
8/4/2008 |
Fluvirin Influenza Virus Vaccine |
2008-2009 United States Formulation | 103837/5358 | Novartis Vaccines and Diagnostics Limited Gaskill Road Liverpool L24 9GR United Kingdom License #1750 |
8/1/2008 |
Alfuria Influenza Virus Vaccine |
2008-2009 United States Formulation | 125254/74 | CSL Limited 1020 First Avenue P.O. Box 60446 King of Prussia, PA 19406-0446 License No. 1764 |
7/30/2008 |
FluLaval Influenza Virus Vaccine |
2008-2009 United States Formulation | 125163/79 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 |
7/28/2008 |
FluMist Influenza Virus Vaccine Live, Intranasal |
2008-2009 United States Formulation | 125020/794 | MedImmune Vaccines, Inc 297 North Bernardo Avenue Mountain View CA 94043 License 1652 |
7/25/2008 |
Fluzone Influenza Virus Vaccine |
Revisions to the Package Insert: To Comply with Physician's Labeling Rule Guidelines |
103914/5157 | Sanofi Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1725 |
7/14/2008 |
Fluzone Influenza Virus Vaccine |
2008-2009 United States Formulation | 103914/5204 | Sanofi Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1725 |
7/14/2008 |
FluMist Influenza Virus Vaccine Live , Intranasal |
To include labeling revisions for the 2008-2009 influenza season | 125020/716 | MedImmune Vaccines, Inc 297 North Bernardo Avenue Mountain View CA 94043 License 1652 |
7/3/2008 |
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant |
To include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert | 125126/758 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
6/12/2008 |
TENIVAC Tetanus and Diphtheria Toxoids Adsorbed For Adult Use |
Use in adults 60 years of age and older for active immunization for the prevention of tetanus and diphtheria | 103171/5045 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 |
6/5/2008 |
FluLaval Influenza Virus Vaccine |
Update the language in the package insert to be consistent with new content and format labeling requirements | 125163/48 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 |
5/16/2008 |
M-M-R II Measles, Mumps, and Rubella Virus Vaccine, Live |
To include epididymitis under Urogenital System in the adverse reactions section of the package insert to reflect reports received during post-marketing surveillance, and to include additional minor editorial changes | 101069/5172 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
5/16/2008 |
NovoSevenRT Coagulation Factor VIIa (Recombinant) |
Room temperature stable formulation | 103665/5231 | Novo Nordisk Inc 100 College Rd West Princeton, NJ 08540 License #1261 |
5/9/2008 |
RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
Include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq | 125122/443 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
4/30/2008 |
cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) |
To include testing for West Nile Virus RNA in post mortem cadaveric (non-heart-beating) donors using an individual testing format | 125245/17 | Roche Molecular Systems, Inc, 4300 Hacienda Drive Pleasanton, CA 94588-2722 License 1636 |
4/2/2008 |
Havrix Hepatitis A Vaccine, Inactivated |
To include coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar®) with Hepatitis A Vaccine Inactivated (Havrix®) for children in the second year of life | 103475/5195 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart, Belgium License 1617 |
3/26/2008 |
ADACEL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed |
To include unit dose syringes as an alternate presentation | 125111/102 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 |
3/18/2008 |
DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
To include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL | 103666/5158 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 |
3/12/2008 |
ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
Revisions to the package insert | 125108/266 | Merck & Co., Inc. P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
2/27/2008 |
YF-Vax Yellow Fever Vaccine |
Changes to the package insert | 103915/5086 | Sanofi Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1725 |
2/12/2008 |
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant |
Changes to the package insert | 125126/578 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
1/9/2008 |
EVICEL Fibrin Sealant (Human) |
Use in general surgery | 125010/105 | Omrix biopharmaceuticals Ltd. 200 Chaussee De Waterloo 1640 Rhode-St-Genese Belgium License 1603 |
1/2/2008 |