2019 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 |
|---|---|---|---|---|
| Menveo Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine |
To include safety and immunogenicity data to support revaccination of adolescents and adults and revisions to the package insert labeling to comply with 21 CFR 201.57 (c)(9)) i - iii and address the Pregnancy and Lactation Labeling Rule, to update Section 13.1, and to add other editorial changes throughout. | 125300/627 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 |
12/20/2019 |
| Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend) | To extend its use to the Grifols DG Gel 8 System and is a companion submission to the Grifols submissions listed below: -Labeling supplement to the Anti-Human Globulin Anti-IgG BLA (BL125445), -Special 510(k) for the Erytra (BK170130), WADiana Compact (BK130025), DG Reader (BK140101) and Erytra Eflexis (BK 180260) devices. |
125621/2 | Diagast NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 Lic. # 1744 |
12/10/2019 |
| Fluzone HD Quadrivalent Influenza Virus Vaccine |
To include the High Dose Quadrivalent formulation for use in persons 65 years of age and older. | 103914/6290 | Sanofi Pasteur Inc. Discovery Drive, Swiftwater, PA 18370-0187 Lic. # 1725 |
11/04/2019 |
| ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion protein |
To revise the labeling based on additional final efficacy and safety data from the completed extension study 8HA01EXT. | 125487/748 | Bioverativ Therapeutics, Inc. 225 Second Avenue Waltham, MA 02451 Lic. # 2078 |
09/27/2019 |
| Wilate von Willebrand Factor/Coagulation Factor VIII Complex (Human) |
To add an indication in adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. | 125251/244 | OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. 121 River Street, Suite 1201 Hoboken, NJ 07030 Lic. # 1646 |
09/25/2019 |
| DG Gel 8 ABO/Rh DG Gel 8 T/S Mono DG Gel 8 ABO/Rh + Kell DG Gel 8 A/B/D DG Gel 8 ABO/Rh +Kell Blood Grouping Reagent, Anti-A (Murine Monoclonal) |
To change the For Further Manufacturing Use (FFMU) antibody solution used to manufacture the Anti-A Blood Grouping Reagent from FFMU antibody solution, clone DAM-1, supplied by –(b)(4)--, to FFMU antibody solutions, clones 16243G2 and 16247E6, supplied by Diagast and manufactured at its LOOS, France facility. | 125449/44 | Diagnostic Grifols, S.A. Medion Grifols Diagnostics AG Avda. de la Gerneralitat, 152 Sant Cugat del Valles Barcelona 08174 Spain Lic. # 1887 |
08/12/2019 |
| ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein |
This submission fulfills the post marketing commitment #2 identified in the March 28, 2014, approval letter for BLA STN BL 125444/0 for Coagulation Factor IX (Recombinant), Fc Fusion Protein. The commitment addressed in this submission is as follows: To evaluate the safety and efficacy of ALPROLIX™ in study 9HB01EXT, an open-label, multi-center evaluation of the long-term safety and efficacy in the prevention and treatment of bleeding episodes in previously treated patients with Hemophilia B. | 125444/651 | Bioverativ Therapeutics, Inc. 225 Second Avenue, Waltham, 02451 Lic. # 2078 |
07/12/2019 |
| Blood Grouping Reagent, Anti-Fya (Monoclonal) (IgG) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by ----(b)(4)--------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125567/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-Jka (Monoclonal) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by ----(b)(4)--------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125568/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-Jkb (Monoclonal) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by -----(b)(4)--------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125569/4 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-S (Monoclonal) (IgG) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by ----(b)(4)-------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125570/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-s (Monoclonal) (IgG) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by ----(b)(4)---------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125571/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-K (Monoclonal) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by ----(b)(4)----------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125572/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Blood Grouping Reagent, Anti-P1 (Murine Monoclonal) | For the new products included in the Rare Bundle of the RevAMP Rare Antisera Monoclonal in vitro diagnostic (IVD), Blood Grouping Reagents. to manufacture monoclonal Blood Grouping Reagents listed below which are supplied by -----(b)(4)--------------------- under a shared manufacturing arrangement - These reagents will be distributed in the United States by Alba under the trade name ALBAclone | 125573/3 | Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
04/18/2019 |
| Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent Influenza Virus Vaccine |
To include the use of a 0.5 mL single dose presentation of Fluzone Quadrivalent formulation in children 6 to <36 months of age | 103914/6208 | Sanofi Pasteur Inc. Discovery Drive, Swiftwater, PA 18370-0187 Lic. # 1725 |
01/23/2019 |
| ADACEL Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
To include re-administration in adolescents and adults following a previous dose | 125111/679 | Sanofi Pasteur Limited 1755 Steeles Avenue West, Toronto, Ontario, Canada M2R 3T4 Lic. # 1726 |
01/11/2019 |