2020 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 |
|---|---|---|---|---|
| Vaxchora Cholera Vaccine Live Oral |
To expand the usage to include children 2 to <18 years of age for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in persons 2 through 64 years of age traveling to cholera-affected areas | 125597/123 | Emergent Travel Health, Inc. 300 Professional Drive Gaithersburg, MD 20879 Lic. # 2199 |
12/23/2020 |
| Fibryga Fibrinogen (Human) |
1. to submit the final study report for Postmarketing Requirement (PMR) #1 noted in the approval letter for STN BL 125612/0 dated June 7, 2017 and 2. to expand the indication for on-demand treatment of acute bleeding episodes to pediatric patients <12 years of age with congenital fibrinogen deficiency. |
125612/67 | Octapharma Pharmazeutika Produktionsges.m.b.H. Octapharma USA, Inc. 117 West Century Road Paramus, NJ 07652 Lic. # 1646 |
12/23/2020 |
| Pneumovax 23 Pneumococcal Vaccine, Polyvalent |
To update the package insert to include data on the sequential administration of Prevnar 13® and PNEUMOVAX® 23 in Sections 6.1 Clinical Trials Experience and 14.2 Immunogenicity | 101094/6617 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. # 0002 |
09/25/2020 |
| IXINITY Coagulation Factor IX (Recombinant) |
To add an indication for routine prophylaxis to reduce the frequency of bleeding episodes in adults and adolescents ≥ 12 years of age with hemophilia B | 125426/177 | Aptevo BioTherapeutics LLC 2401 4th Avenue, Suite 1050 Seattle, WA 98121 Lic. # 2054 |
09/25/2020 |
| HAEGARDA C1 Esterase Inhibitor (Human) |
To expand the indication to include pediatric patients 6 years of age and older, and update the “Clinical Studies” and “Use in Specific Populations” sections of the package insert based on data from Phase 3 open label, long-term safety study CSL830_3002 | 125606/185 | CSL Behring GmbH 1020 First Avenue P.O. Box 61501 King of Prussia, PA 19406 Lic. # 1765 |
09/24/2020 |
| Boostrix Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) |
To include safety and immunogenicity data to support use as an additional dose 9 years or more after the initial dose of a Tdap vaccine for active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older | 125106/1403 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 |
09/10/2020 |
| Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant |
To update the Adverse Reactions and Clinical Studies sections of the package insert to include data from Clinical Trial V503-004, “An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27 to 45 Year-Olds) compared to Young Adult Women (16 to 26 Year-Olds).” | 125508/787 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. #0002 |
08/20/2020 |
| XYNTHA SOLOFUSE; XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin Free |
To include a new indication of routine prophylaxis to reduce the frequency of bleeding episodes in children and adults with hemophilia A. | 125264/1670 | Wyeth Pharmaceuticals, LLC 235 E. 42nd St 219/9/1 New York, NY 10017 Lic. #0003 |
08/13/2020 |
| BeneFIX BeneFIX RTS Coagulation Factor IX (Recombinant) |
New Indication: for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease) | 103677/6512 | Wyeth Pharmaceuticals LLC 235 East 42nd Street New York, NY 10017-7555 Lic. #0003 |
06/26/2020 |
| Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant |
To expand the indication to include the prevention of oropharyngeal and other head and neck cancers caused by HPV. | 125508/868 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 Lic. #0002 |
06/12/2020 |
| Blood Grouping Reagent, Anti-e (Monoclonal)(Formulated for Automated Testing) | To include additional Anti-e FFMU cell lines MS16 and MS21, from Millipore located in Loss, France, for Further Manufacturing Use (FFMU) in vitro substances and to validate its use on the Beckman Coulter Automated System PK7400. | 125176/38 | 125176/38 DIAGAST NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 Lic. #1744 |
05/07/2020 |
| Micrurus Fulvius Antivenin (Micrurus fulvius) |
Post Marketing Commitment to STN 101099/5105 for -(b)(4)---------------------------- on Lot H42803 Envenomation by Micrurus fulvius |
101099/5109 | Wyeth Pharmaceuticals, Inc. Pfizer Essential Health, GRA Brands 235 East 42nd Street New York, NY 10017 Lic. # 0003 |
03/27/2020 |
| FLUAD QUADRIVALENT Influenza Vaccine, Adjuvanted |
For active immunization of persons 65 years of age and older against influenza disease caused by seasonal influenza virus subtypes A and types B contained in the vaccine | 125510/143 | Seqirus Inc. 50 Hampshire Street, 9th Floor Cambridge, MA 02139 Lic. # 2049 |
02/21/2020 |
| Nuwiq Antihemophilic Factor (Recombinant), rAHF |
To include wording changes in Product Information based on submission of new clinical data from study GENA-21 and study GENA-13 | 125555/137 | Octapharma Pharmazeutika Produktionsges.m.b.H. Octapharma USA Inc. 121 River Street, Suite 1201 Hoboken, NJ 07030 Lic. # 1646 |
01/29/2020 |
| Agriflu Influenza Virus Vaccine |
To include data from three post-approval requirement/commitment studies conducted in pediatric and adult populations | 125297/118 | Seqirus Inc. 50 Hampshire Street, 9th Floor Cambridge, MA 02139 Lic. # 2049 |
01/28/2020 |