U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. 2019 Biological License Application Supplement Noteworthy Approvals
  1. Development & Approval Process (CBER)

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.

2019 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
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