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  1. Development & Approval Process (CBER)

2017 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.

2017 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
ALPROLIX
Coagulation Factor IX(Recombinant), Fc Fusion Protein
To include the completed pediatric study final report for reportable PMC #1 in the approval letter issued on March 28, 2014 for STN 125444/0 with revised package insert labeling. 125444/225 Bioverativ Therapeutics, Inc.
225 Second Avenue, Waltham, MA 02451

Lic # 2078
11/3/2017
Privigen
Immune Globulin Intravenous (Human), 10% Liquid
For a proposed indication for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 125201/728 CSL Behring AG
Wankdorfstrasse 10,
3000 Berne 22,
Switzerland

Lic # 1766
9/14/2017
Prolastin; Prolastin-C
Alpha-1-Proteinase Inhibitor (Human)
To include a new alanine stabilized liquid formulation as an alternate dosage form to the currently licensed lyophilized Prolastin-C, and to submit a new package insert and labeling for the alternate dosage form, for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe deficiency of Alpha-1-PI (alpha-1 -antitrypsin deficiency). 103174/6160 Grifols Therapeutics Inc.
8368 U.S. 70 Bus Hwy W,
Clayton, NC, 27520

Lic # 1871
9/8/2017
AFLURIA; Afluria Quadrivalent
Influenza Vaccine
To extend the indication for use in persons 5 years and older. 125254/642 Seqirus Pty Ltd.
45 Poplar Road,
Parkville Victoria,
Australian Capital
Territory 3052,
Australia

Lic # 2044
8/31/2017
T.R.U.E. TEST
Thin-Layer Rapid Use Epicutaneous Patch Test
To use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 substances included on the T.R.U.E. TEST panels. 103738/5162 SmartPractice Denmark ApS
3400 East
McDowell Road,
Phoenix, AZ,
85008

Lic # 1888
8/25/2017
Zostavax
Zoster Vaccine Live
To include safety and immunogenicity data to support the concomitant administration of ZOSTAVAX and inactivated influenza vaccines, including quadrivalent inactivated influenza vaccines. 125123/1946 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse
Station, NJ, 08889-0100

Lic # 0002
8/3/2017
Blood Grouping Reagent, Anti-D (Monoclonal) (IgM) Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT reagents will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) which is manufactured at Edinburgh, United Kingdom. 125304/35 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT,
United Kingdom

Lic # 1807
6/16/2017
Blood Grouping Reagent, Anti-N (Murine Monoclonal)(IgG) Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT reagents will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) which is manufactured at Edinburgh, United Kingdom. 125309/30 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT,
United Kingdom

Lic # 1807
6/16/2017
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT reagents will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) which is manufactured at Edinburgh, United Kingdom. 125310/30 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT,
United Kingdom

Lic # 1807
6/16/2017
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT reagents will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) which is manufactured at Edinburgh, United Kingdom. 125311/29 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT,
United Kingdom

Lic # 1807
6/16/2017
Blood Grouping Reagent, Anti-D (Monoclonal Blend) Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT reagents will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) which is manufactured at Edinburgh, United Kingdom. 125314/34 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT,
United Kingdom

Lic # 1807
6/16/2017
CroFab
Crotalidae Polyvalent Immune Fab (Ovine)
To modify the package insert with new information from pediatric and geriatric subgroup analyses from a retrospective medical chart review (Protocol MC03/03/05). 103788/5341 BTG International Inc. Five Tower Bridge,
West Conshohocken, PA, 19428-2998

Lic # 1861
05/8/2017
Thymoglobulin
Anti-thymocyte Globulin (Rabbit)
To expand /the indication to include prophylaxis of acute rejection in patients receiving a kidney transplant. 103869/5365 Genzyme Corporation
500 Kendall Street,
Cambridge, MA, 02142

Lic # 1596
04/21/2017
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
To update the United States Prescribing Information (USPI) to include results from the study B1851138 “A Phase 4, Randomized, Double-Blind Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine in Adults 50 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine Prior to Study Enrollment”. 125324/1561 Wyeth Pharmaceuticals Inc.
500 Arcola Road,
Collegeville, NY, 10965

Lic # 3
3/24/2017
ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
To include implementation of the --(b)(4)--------------- -------------------------- method in the production of Varicella Zoster Virus --(b)(4)-- ------------------ for varicella-zoster virus (Oka/Merck strain) drug substance. 125108/856 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse Station, NJ, 08889-0100

Lic # 2
3/15/2017
Zostavax
Zoster Vaccine Live
To include implementation of the --(b)(4)--------------- -------------------------- method in the production of Varicella Zoster Virus --(b)(4)-- ------------------ for varicella-zoster virus (Oka/Merck strain) drug substance. 125123/1900 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse Station, NJ, 08889-0100

Lic # 2
3/15/2017
TRUMENBA
Meningococcal Group B Vaccine
To include data from two confirmatory clinical studies to verify and describe the clinical benefit of the 3-dose schedule (a dose administered at 0, 1-2, and 6 months) of Trumenba; a study to further describe the safety of Trumenba in persons 10 years to less than 26 years of age; and a study to assess the concomitant use of Trumenba with Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed in persons 10 to <13> 125549/173 Wyeth Pharmaceuticals Inc.
500 Arcola Road,
Collegeville, NY, 10965

Lic # 3
3/13/2017
Anti-Fyb ALBAsera(R); Anti-Fyb ALBAsera
Blood Grouping Reagent, Anti-Fyb
Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents are placed on the market under the trade name ORTHO(TM) Sera. The RASCAT products will be distributed by Ortho-Clinical Daignostics (Raritan, NJ) and are intended for use with the Ortho ID-Micro Typing system (TM) manufactured by Ortho-Clinical diagnostics. 125342/15 Alba Bioscience Limited
Ellen's Glen Road,
Edinburgh EH17 7QT,
United kingdom

Lic # 1807
3/13/2017
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
To include expansion of the indication to include prevention of rotavirus gastroenteritis caused by type G9. 125122/1309 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse Station, NJ, 08889-0100

Lic # 2
02/23/2017
Varivax
Varicella Virus Vaccine Live
To include implementation of the ------(b)(4)-----------------------------------------” method in the production of Varicella Zoster Virus ----(b)(4)----------------- for VARIVAX® Drug Substance manufacture. 103552/6047 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse Station, NJ, 08889-0100

Lic # 2
02/17/2017
Gammaplex
Immune Globulin Intravenous (Human), 5% Liquid
To include a 10% formulation to treat Primary Humoral Immunodeficiency and Chronic Immune Thrombocytopenic Purpura. 125329/151 Bio Products Laboratory
Dagger Lane,
Hertfordshire, WD6 3BX,
United Kingdom

Lic # 1811
02/6/2017