2006 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 |
|---|---|---|---|---|
| M-M-R II Measles, Mumps, and Rubella Virus Vaccine, Live |
Changes to the package insert | 101069/5116 | Merck & Co., Inc P.O. Box 1000 North Wales, PA 19454-1099 License 0002 |
12/29/2006 |
| Flebogamma 5% DIF Immune Globulin Intravenous (Human) |
Addition of a viral inactivation step, new manufacturing facility, and a 400mL fill size | 125077/47 | Instituto Grifols, S.A. 2 Can Guasch St Poligono Levante Parets del Valles Barcelona, Spain 08150 License 1181 |
12/21/2006 |
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
Changes to the package insert | 103905/5332 | Wyeth Pharmaceuticals Inc. 401 North Middleton Rd Pearl River , New York 10965 License 0003 |
11/22/2006 |
| HibTITER Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) |
Changes to the package insert | 103578/5063 | Wyeth Pharmaceuticals Inc 401 North Middletown Rd Pearl River, NY 10965 License 0003 |
11/17/2006 |
| Varivax Varicella Virus Vaccine Live |
Revised Package Insert | 103552 / 5141 | Merck & Co., Inc. P.O. Box 1000, UG2D-68 North Wales, PA 19454-1099 License 0002 |
11/9/2006 |
| DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Revised labeling | 103666/5071 | Sanofi Pasteur Ltd 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 |
11/8/2006 |
| NovoSeven Coagulation Factor VIIa (Recombinant) |
Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia | 103665/5119 | Novo Nordisk A/S Novo Nordisk Pharmaceuticals, Inc. 100 College Rd West Princeton, NJ 08540 License 1261 |
10/13/2006 |
| APTIMA HIV-1 RNA Qualitative Assay Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic) |
Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. | 103966/5040 | Gen-Probe Inc 10210 Genetic Center Dr San Diego, CA 92121 License 1592 |
10/4/2006 |
| Menactra Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
Revised Package Insert | 125089/104 | Sanofi Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1725 |
10/3/2006 |
| Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
Manufacture of the Pertussis antigen component | 103666/5069 | Sanofi Pasteur, Ltd. 1755 Steeles Ave West Toronto, Ontario Canada M2R3T4 License 1726 |
8/23/2006 |
| Tisseel VH Kit Fibrin Sealant (Tisseel) |
To include the incorporation of a second, independent virus inactivation step (solvent/detergent treatment), modifications to the manufacturing process and manufacturing locations within the Vienna facilities and the introduction of a frozen liquid presentation of the product | 103980/5121 | Baxter Healthcare Corp One Baxter Way Westlake Village, CA 91362 License 0140 |
7/27/2006 |
| Fluarix Influenza Virus Vaccine |
New Formulation: 2006-2007 United States formulation |
125127/139 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 |
7/25/2006 |
| Fluvirin Influenza Virus Vaccine |
Labeling revisions and 2006-2007 United States formulation | 103837/5104 | Chiron Vaccines Ltd Gaskill Road Speke, Liverpool, L24 9GR, UK License 1720 |
7/21/2006 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
New Formulation: 2006-2007 United States formulation |
125020/238 | MedImmune Vaccines, Inc 297 N. Bernardo Ave Mountain View, CA 94043 License 1652 |
7/21/2006 |
| Varivax Varicella Virus Vaccine Live |
Revised Package Insert | 103552/5124 | Merck & Co., Inc Sumneytown Pike P.O. Box 4, BLB-22 West Point, PA 19486 License 0002 |
7/12/2006 |
| Benefix Coagulation Factor IX (Recombinant) |
Revised Package Insert | 103677/5261 | Wyeth Pharmaceuticals P.O. Box 8299 Philadelphia, PA 19101-8299 License 0003 |
7/11/2006 |
| Fluzone Influenza Virus Vaccine |
Labeling revisions for the 2006-2007 influenza season | 103914/5125 | Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370 License 1725 |
7/10/2006 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
Labeling revisions for the 2006-2007 influenza season | 125020/201 | MedImmune Vaccines, Inc 297 N. Bernardo Ave Mountain View, CA 94043 License 1652 |
6/15/2006 |
| Pediarix DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine |
Revised package insert for a safety and immunogenicty of a three dose series of Pediarix when administered with other recommended US-licensed vaccines including Prevnar | 103907/5034 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 |
4/4/2006 |
| Havrix Hepatitis A Vaccine Inactivated |
Package insert labeling changes regarding geriatric use | 103475/5100 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 |
2/21/2006 |
| OCTAGAM Immune Globulin Intravenous, Human 5% |
Revised Package Insert Include labeling changes to the "Warnings/Blood Glucose Testing" and "Precautions/Drug/Laboratory Test Interactions" sections of the package insert strengthening the warning of effects of maltose in the product |
125062/57 | OCTAPHARMA Pharmazeutika Produktionsges.m.b.H Oberlaaer Strasse 235 A-1100 Vienna Austria License 1646 |
2/3/2006 |
| Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed |
Revised Package Insert | 125111/2 | Sanofi Pasteur Limited 1755 Steeles Ave West Toronto, Ontario M2R 3T4 Canada License 1726 |
1/23/2006 |
Complete list of currently licensed products and establishments