Vaccines, Blood & Biologics
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2011 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 |
|---|---|---|---|---|
| Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | Include the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older. | 125324/262 | Wyeth Pharmaceuticals, Inc. 401 N. Middletown Rd Pearl River, NY 10965 License 0003 | 12/30/2011 |
| Berinert C1 Esterase Inhibitor (Human) | To include treatment of acute abdominal, facial, or laryngeal attacks of Hereditary Angioedema (HAE) in adult and adolescent patients and to submit the PMR Final Study Report under 505(o) - Completion of Planned Ongoing Open Label Extension Study CE1145_3003 (IMPACT II) for laryngeal HAE attacks. | 125287/110 | CSL Behring GmbH 1020 First Avenue King of Prussia, PA 19406-0901 License 1765 | 12/22/2011 |
| Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | New indication: for routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with Hemophilia A. | 125063/822 | Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 License 0140 | 12/14/2011 |
| Afluria Influenza Virus Vaccine | Final Post Marketing Commitment Study Reports covering PMCs 1 and 2 under STN 125254/0 and 1 and 2 under STN 125254/132. | 125254/259 | CSL Limited 45 Poplar Road Parkville, Victoria 3052 Australia License 1764 | 12/2/2011 |
| Menactra Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Data to update the package insert with results from a retrospective study to assess the risk of Guillain-Barre Syndrome (GBS) following administration of Menactra. | 125089/424 | Sanofi Pasteur Inc. Discovery Dr Swiftwater, PA 18370-0187 License 1725 | 12/1/2011 |
| ABBOTT ESA Chagas Trypanosoma cruzi (E. coli, Recombinant) | In vitro enzyme strip assay intended for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi) in human serum and plasma specimens; intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed screening test for antibodies to T cruzi. | 125361/23 | Abbott Laboratories 100 Abbott Park Rd Abbott Park, IL 60064 License 0043 | 11/18/2011 |
| Pneumovax 23 Pneumococcal Vaccine, Polyvalent | Allow the addition of information regarding concomitant administration with ZOSTAVAX® to the labeling and revise the labeling to comply with the Physician’s Labeling Rule (PLR). | 101094/5324 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 10/27/2011 |
| Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid | Inclusion of efficacy and safety data from European Study ZLB06_001CR into the package insert. | 125350/136 | CSL Behring AG Wankdorfstrasse 10 3000 Berne 22 Switzerland License 1766 | 10/3/2011 |
| ARTISS Fibrin Sealant (Human) | Extend the indication to adhere tissue flaps during facial rhytidectomy surgery (face-lift). | 125266/194 | Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 License 0140 | 8/29/2011 |
| Havrix Hepatitis A Vaccine Inactivated | Clinical data to support the coadministration with M-M-RII and VARIVAX and to fulfill PMCs 1 and 3 under STN 103475/5090. | 103475/5343 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 7/22/2011 |
| Gammagard Liquid Immune Globulin Infusion (Human) | Treatment of primary immunodeficiency disorders (PID) associated with defects in humoral immunity by subcutaneous route of administration. | 125105/708 | Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 License 0140 | 7/22/2011 |
| Cervarix Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant | Safety and immunogenicity data to support use in females as young as 9 years of age. | 125259/132 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 7/19/2011 |
| Pentacel Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated | Changes to the package insert regarding the dosage and administration claim. | 125145/150 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 | 7/15/2011 |
| Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | Package insert revisions to update the safety data on use of a fifth dose of DAPTACEL® in children four through six years of age who received four doses of PENTACEL®. | 103666/5254 | Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario M2R 3T4 Canada License 1726 | 7/15/2011 |
| Afluria Influenza Virus Vaccine | 2011-2012 United States formulation and to revise the age indication from 6 months and older to 5 years and older. | 125254/303 | CSL Limited 45 Poplar Rd Parkville, Victoria Australia 3052 License 1764 | 7/15/2011 |
| BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | To include immunogenicity and safety data to support the use of Boostrix® in individuals 65 years of age and older. | 125106/680 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 7/8/2011 |
| FluLaval Influenza Virus Vaccine | 2011-2012 United States formulation | 125163/204 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 | 6/30/2011 |
| Fluarix Influenza Virus Vaccine | 2011-2012 United States formulation | 125127/472 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 6/30/2011 |
| FluMist Influenza Virus Vaccine Live, Intranasal | 2011-2012 United States formulation | 125020/1670 | MedImmune, LLC One MedImmune Way Gaithersburg, MD 20878 License 1799 | 6/30/2011 |
| Fluvirin Influenza Virus Vaccine | 2011-2012 United States formulation | 103837/5571 | Novartis Vaccines and Diagnostics Limited Gaskill Rd Speke, Liverpool L24 9GR License 1750 | 6/30/2011 |
| Fluzone Influenza Virus Vaccine | 2011-2012 United States formulation | 103914/5449 | Sanofi Pasteur Inc. Discovery Dr Swiftwater, PA 18370-0187 License 1725 | 6/27/2011 |
| FluLavalInfluenza Virus Vaccine | To include data in the prescribing information from a clinical endpoint study and a non-inferiority immunogenicity study conducted in adults. | 125163/176 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 | 6/9/2011 |
| FluMist Influenza Vaccine Live, Intranasal | Package insert revisions to include data from clinical trials characterizing vaccine virus shedding in healthy subjects and from small studies of immuno- compromised subjects after administration of FluMist | 125020/1465 | MedImmune, LLC One MedImmune Way Gaithersburg, MD 20878 License 1799 | 5/26/2011 |
| Fluzone Influenza Virus Vaccine | Active immunization of persons 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine; New ro ute of admin: Intradermal. | 103914/5369 | Sanofi Pasteur Inc. Discovery Dr Swiftwater, PA 18370-0187 License 1725 | 5/9/2011 |
| Menactra Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Safety and immunogenicity data to support use in children 9 through 23 months of age to prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135. | 125089/395 | Sanofi Pasteur Inc. Discovery Dr Swiftwater, PA 18370-0187 License 1725 | 4/22/2011 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent | Package insert revisions regarding results of a post marketing safety study (Study 019) | 125122/685 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 4/8/2011 |
| GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant | To include information in the "Limitations of Use" section of the prescribing information that Gardasil does not prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. Information on studies in women 27 through 45 years of age is also included. | 125126/773 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 4/5/2011 |
| Menveo Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | Revisions to the package insert to include the re-evaluated immunogenicity data due to a transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission (125300/0). | 125300/7 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton Street Emeryville, CA 94608-2916 License 1751 | 4/1/2011 |
| Menveo Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | Revisions to the package insert to include the re-evaluated immunogenicity data due to a transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission (125300/0). | 125300/49 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton Street Emeryville, CA 94608-2916 License 1751 | 4/1/2011 |
| Zostavax Zoster Vaccine Live | Prevention of herpes zoster (shingles) in individuals 50-59 years of age and older. | 125123/734 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 3/24/2011 |
| Boostrix Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | Revised package insert in the PLR format that includes clinical data describing the concomitant use of Boostrix and Menactra (Fulfilling PMC #1 from STN 125106/386) | 125106/628 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 3/17/2011 |
| DECAVAC Tetanus and Diphtheria Toxoids Adsorbed For Adult Use | Package insert revisions to include additional safety and immunogenicity data from the DECAVAC group of study Td506. | 103921/5143 | Sanofi Pasteur, Inc. Discovery Dr Swiftwater, PA 18370-0187 License 1725 | 3/7/2011 |
| Menveo Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | To include safety and immunogenicity data to support use in children 2 through 10 years of age. | 125300/95 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton St. Emeryville, CA 94608-2916 License 1751 | 1/28/2011 |
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