2007 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.
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
To include the addition of "crying" to the Adverse Reaction - Postmarketing Experience section of the package insert | 103905/5495 | Wyeth Pharmaceuticals Inc 401 North Middletown Rd Pearl River NY 10965 License 0003 |
12/11/2007 |
| M-M-R II Measles, Mumps, and Rubella Virus Vaccine, Live |
Change in the labeled potency of the mumps component from no less than 20,000 TCID50 to no less than 12,500 TCID50 per dose at end of expiry | 101069/5061 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
12/6/2007 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
Changes to the package insert | 125122/314 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
11/28/2007 |
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
Changes to the package insert | 103905/5470 | Wyeth Pharmaceuticals Inc 401 North Middletown Rd Pearl River NY 10965 License 0003 |
11/13/2007 |
| Fluvirin Influenza Virus Vaccine |
Update package insert | 103837/5108 | Novartis Vaccines and Diagnostics Limited Gaskill Road, Speke Liverpool L24 9GR United Kingdom License 1750 |
11/9/2007 |
| ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
Package insert revisions | 125108/218 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
10/23/2007 |
| Humate-P Antihemophilic Factor/von Willebrand Factor Complex (Human) |
To include a change in the storage conditions (up to 25ºC) for the complete shelf life of 24 months | 103960/5346 | CSL Behring GmbH 1020 First Avenue King of Prussia, PA 19406-0901 Licence 1765 |
10/19/2007 |
| Menactra Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine |
Expanded age indication for subjects 2-10 years of age | 125089/2 | Sanofi Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1725 |
10/18/2007 |
| Dryvax Smallpox Vaccine, Dried, Calf Lymph Type |
Labeling Supplement: Include additional language regarding skin lesions at the smallpox vaccination site |
101106/5089 | Wyeth Pharmaceuticals, Inc 401 North Middletown Rd Pearl River NY 10965 License 0003 |
10/2/2007 |
| Gardasil Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
Changes to the package insert | 125126/428 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
10/1/2007 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
Revised Labeling: Include the addition of G9 P1A[8] Serotype case reduction in the "Clinical Studies" section of the package insert, and revisions of the label in the Physician's Labeling Rule format |
125122/201 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
9/28/2007 |
| M-M-R II Measles, Mumps, and Rubella Virus Vaccine, Live |
Changes to the package insert | 101069/5143 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
9/24/2007 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
Indication Revision: For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine |
125020/322 | MedImmune Vaccines, Inc (a wholly owned subsidiary of MedImmune, Inc.) 297 North Bernardo Ave Mountain View, CA 94043 License 1652 |
9/19/2007 |
| FluLaval Influenza Virus Vaccine |
New Formulation: 2007-2008 United States formulation |
125163/39 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 |
9/12/2007 |
| COBAS AmpliScreen HBV Test Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) |
Changes in the labeling, testing requirement, and an increase in reagent refrigerator cycles | 125090/21 | Roche Molecular Systems, Inc 4300 Hacienda Drive P.O. Box 9002 Pleasanton, CA 94566-0990 License 1636 |
8/16/2007 |
| Fluarix Influenza Virus Vaccine |
New Formulation: 2007-2008 United States formulation |
125127/229 | GlaxoSmithKline Biologicals 2301 Renaissance Boulevard Building 510, P.O. Box 61540 King of Prussia, PA 19406-2772 License 1617 |
7/24/2007 |
| Fluvirin Influenza Virus Vaccine |
New Formulation: 2007-2008 United States formulation |
103837/5240 | Novartis Vaccines and Diagnostics Limited Gaskill Road, Speke Liverpool L24 9GR United Kingdom License 1750 |
7/24/2007 |
| Fluzone Influenza Virus Vaccine |
New Formulation: 2007-2008 United States formulation |
103914/5167 | Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370 License 1725 |
7/13/2007 |
| Zostavax Zoster Vaccine Live |
To include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine | 125123/90 | Merck & Co., Inc. P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
7/6/2007 |
| Carticel Autologous Cultured Chondrocytes |
Revised Package Insert: To include safety and efficacy data from the Study of the Treatment of Articular Repair; and formatting and content changes in compliance with the Physician's Labeling Rule |
103661/5155 | Genzyme Biosurgery 55 Cambridge Parkway Cambridge, MA 02142 License 1659 |
6/21/2007 |
| 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) |
To add the Procleix TIGRIS System for use with the Procleix Ultrio Assay | 125113/2 | Gen-Probe Inc 10210 Genetic Center Dr San Diego, CA 92121 License 1592 |
5/23/2007 |
| COBAS AmpliScreen HIV-1 Test, version 1.5 Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction) |
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles | 125059/37 | Roche Molecular Systems, Inc 4300 Hacienda Drive P.O. Box 9002 Pleasanton CA 94566-0990 License 1636 |
5/23/2007 |
| COBAS AmpliScreen HCV Test Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) |
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles | 125045/5034 | Roche Molecular Systems, Inc 4300 Hacienda Drive P.O. Box 9002 Pleasanton CA 94566-0990 License 1636 |
5/22/2007 |
| RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) |
Changes to the package insert | 101066/5159 | Merck & Co., Inc. P.O. Box 4 West Point, PA 19486-0004 License 0002 |
5/15/2007 |
| EVICEL Fibrin Sealant (Human) |
An adjunct to hemostasis for use in patients undergoing liver or vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical | 125010/74 | Omrix biopharmaceuticals Ltd. 113 SE 5th Street Oak Island, NC 28465 License 1603 |
5/9/2007 |
| VAQTA Hepatitis A Vaccine, Inactivated |
Changes to the package insert | 103606/5209 | Merck & Co., Inc P.O. Box 4 West Point, PA 19486-0004 License 0002 |
5/8/2007 |
| ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
Changes to the package insert | 125108/170 | Merck & Co., Inc P.O. Box 4 West Point, PA 19486-0004 License 0002 |
5/8/2007 |
| Aralast NP Alpha-1-Proteinase Inhibitor (Human) |
For further manufacture into Alpha-1-Proteinase Inhibitor (A1PI) | 125039/263 | Baxter Healthcare Corp One Baxter Way Westlake Village, California 91362 License 0140 |
5/4/2007 |
| Humate-P Antihemophilic Factor/von Willebrand Factor Complex (Human) |
Additional Indication: For adult and pediatric patients with von Willebrand disease for the prevention of excessive bleeding pre and post surgery | 103960/5243 | CSL Behring GmbH. 1020 First Avenue King of Prussia, PA 19406 License 1765 |
4/27/2007 |
| GARDASIL Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
Changes to the package insert | 125126/159 | Merck & Co., Inc. P.O. Box 4 West Point, PA 19486-0004 License 0002 |
4/3/2007 |
| Menactra Meningococcal Groups (A, C, Y and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
To include a single dose syringe presentation | 125089/3 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 License 1725 |
3/30/2007 |
| TWINRIX Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine |
Revised Package Insert: For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose | 103850/5162 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart Belgium License 1617 |
3/28/2007 |
| Rhophylac Rho(D) Immune Globulin Intravenous (Human) |
Expanded indication: for the treatment of Rho(D) positive, non-splenectomized adult patients with chronic Immune Thrombocytopenia Purpura (ITP) | 125070/149 | ZLB Behring AG 1020 First Avenue King of Prussia, PA 19406-0901 License 1710 |
3/26/2007 |
| Pediarix Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined |
Labeling Changes | 103907/5195 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart Belgium License 1617 |
3/16/2007 |
| Procleix West Nile Virus (WNV) Assay West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic |
Revised Labeling: To perform the Procleix WNV Assay with the Procleix TIGRIS System |
125121/17 | Gen-Probe Inc 10210 Genetic Center Dr San Diego, CA 92121 License 1592 |
3/2/2007 |
| ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
Revised Package Insert | 125108/164 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA. 19486 License 0002 |
2/27/2007 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
Changes to the Package Insert: Including cases of intussusception and hematochezia seen post-marketing | 125122/219 | Merck & Co., Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
2/12/2007 |
| Alphanate Antihemophilic Factor (Human) |
For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. | 102475/5002 | Grifols Biologicals Inc 5555 Valley Boulevard Los Angeles, CA 90032 License 1694 |
1/31/2007 |
| MERUVAX II Rubella Virus Vaccine Live |
Revised Package Insert | 101075/5074 | Merck & Co., Inc. P.O. Box 1000, UG2D-68 North Wales, PA 19454-1099 License 0002 |
1/31/2007 |
| ATTENUVAX Measles Virus Vaccine Live |
Revised Package Insert | 101068/5080 | Merck & Co., Inc. P.O. Box 1000, UG2D-68 North Wales, PA 19454-1099 License 0002 |
1/31/2007 |
| Engerix-B Hepatitis B Vaccine (Recombinant) |
Thimerosal-free formulation | 103239/5109 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart Belgium License 1617 |
1/30/2007 |
| GARDASIL Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
Revised Package Insert | 125126/109 | Merck & Co., Inc. P.O. Box 1000, UG2D-68 North Wales, PA 19454-1099 License 0002 |
1/30/2007 |
| Pediarix Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined |
Revised Package Insert: For a preservative free/thimerosal free formulation |
103907/5148 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart Belgium License 1617 |
1/29/2007 |
| TWINRIX Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine |
Revised Package Insert | 103850/5173 | GlaxoSmithKline Biologicals Rue de I'Institut 89 B1330 Rixensart Belgium License 1617 |
1/19/2007 |
| Tubersol Tuberculin, Purified Protein Derivative |
Revised Package Insert | 103941/5044 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 CANADA License 1726 |
1/8/2007 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
New Formulation: Convert from the frozen formulation to a liquid formulation |
125020/90 | MedImmune Vaccines, Inc (a wholly owned subsidiary of MedImmune, Inc.) 297 North Bernardo Ave Mountain View, CA 94043 License 1652 |
1/5/2007 |
Complete list of currently licensed products and establishments