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.
| 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 |