Vaccines, Blood & Biologics
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2012 Biological License Application Supplement 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 | Action | STN | Manufacturer/ License No. | Approval Date |
|---|---|---|---|---|
| Fluarix Quadrivalent Influenza Virus Vaccine | To include a quadrivalent influenza virus vaccine formulation for use in persons 3 years of age and older | 125127/513 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 12/14/2012 |
| Rotarix Rotavirus Vaccine, Live, Oral | Package insert update to reflect the results from final analysis of the Mexico PASS study. | 125265/356 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 9/7/2012 |
| Pentacel Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated | To include safety information regarding the risk of apnea in premature infants to the Warnings and Precautions section of the package insert. | 125145/201 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 | 7/27/2012 |
| Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | To include safety information regarding the risk of apnea in premature infants to the Warnings and Precautions section of the package insert. | 103666/5277 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 | 7/27/2012 |
| VAQTA Hepatitis A Vaccine Inactivated | To support concomitant administration of VAQTA® with Diptheria, Tetanus, acelluar Pertussis and Haemophilus influenzae type b vaccines in 12 to 23 months old children. | 103606/5469 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 7/18/2012 |
| Gammagard Liquid Immune Globulin Infusion (Human) | Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). | 125105/961 | Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 License 0140 | 6/22/2012 |
Rotarix | To update the package insert and patient package insert to reflect transmission data from Twins Transmission Study Rota-052. | 125265/359 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 6/8/2012 |
| Procleix Ultrio Plus Assay Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/ Synthetic) | To include Procleix Ultrio Plus Assay, a qualitative in vitro nucleic acid assay system intended to screen individual or pooled plasma and serum specimens from human donors for human immunodeficiency virus type I (HIV1) RNA, hepatitis C virus (HCV) RNA, and hepatitis B virus (HBV) DNA on the Procleix TIGRIS System. | 125113/48 | Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121 License 1592 | 5/25/2012 |
| BioThrax Anthrax Vaccine Adsorbed | To change the dosing schedule from a five-dose primary schedule at 0, 1, 6, 12, 18 months with annual booster to a three dose primary schedule at 0, 1, 6 months, with boosters at 12 and 18 months after initiation of the primary series, and annual boosters thereafter. | 103821/5203 | Emergent BioDefense Operations Lansing LLC 3500 N. Martin Luther King, Jr., Blvd Lansing, MI 48906 License 1755 | 5/17/2012 |
| Xyntha Antihemophilic Factor (Recombinant), Plasma/Albumin Free | Labeling revisions to demonstrate the safety and efficacy of Xyntha for surgical prophylaxis in patients with hemophilia A. | 125264/797 | Wyeth Pharmaceuticals Inc. 401 North Middletown Rd Pear River, NY 10965 License 0003 | 4/12/2012 |
| T.R.U.E. TEST Layer Rapid Use Epicutaneous Test | To add seven new allergens to the T.R.U.E. TEST | 103738/5074 | Mekos Laboratories AS Herredsvejen 2 DK 3400 Hillerod Denmark License 1623 | 2/29/2012 |
| Flumist Quadrivalent Influenza Vaccine Live, Intranasal | To include a quadrivalent formulation containing two influenza A subtype viruses and two type B viruses. | 125020/1668 | MedImmune, LLC One MedImmune Way Gaithersburg, MD 20878 License 1799 | 2/29/2012 |
| Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | To include geriatric use language in the label consistent with the geriatric labeling requirements, and to revise the content and format of the label according to current regulations. | 125111/304 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 | 2/16/2012 |
TISSEEL Fibrin Sealant (Tisseel) | To support the indication extension for general adjunct to hemostasis. | 103980/5601 | Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 License 0140 | 1/25/2012 |
| Revision to the package insert to reflect the final clinical study data. | 125035/162 | Cangene Corporation 155 Innovation Dr. Winnipeg, R3T 5Y3 Manitoba, Canada License 1201 | 1/13/2012 | |
HepaGam BT Hepatitis B Immune Globulin Intravenous (Human) | Revision to the package insert to reflect the final clinical study data. | 125237/125 | Cangene Corporation 155 Innovation Dr. Winnipeg, R3T 5Y3 Manitoba, Canada License 1201 | 1/13/2012 |
| Cinryze C1 Esterase Inhibitor(Human) | Incorporate additional safety data from the open-label uncontrolled routine prophylaxis trial protocol LEVP2006-4 ("Change 3" study) into the labeling. | 125267/312 | ViroPharma Biologics, Inc. 730 Stockton Drive Extoh , PA 19341 License 1833 | 1/9/2012 |
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