2021 Biological License Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Prehevbrio Prehebrio Trehebri Hepatitis B Vaccine (Recombinant) |
Indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years and older. | 125737/0 | VBI Vaccines (Delaware) Inc. Biologics Consulting Group, Inc. 1555 King Street Suite 300 Alexandria, VA 22314 Lic. # 2219 |
11/30/2021 |
| RETHYMIC Allogeneic processed Thymus Tissue |
Indicated for immune reconstitution in pediatric patients with congenital athymia. | 125685/0 | Enzyvant Therapeutics GmbH 300 Morris Street, 7th Floor Durham, NC 27701 Lic. # 2100 |
10/08/2021 |
| Source Plasma | For further manufacturing of injectable products under License No. 2260 | 125756/0 | BioTek America, LLC 5750 Johnston Street, Suite 302 Lafayette, LA 70503 Lic. # 2260 |
09/24/2021 |
| COMIRNATY COVID-19 Vaccine, mRNA |
Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. | 125742/0 | BioNTech Manufacturing GmbH Pfizer Inc. 235 East 42nd Street New York, NY 10017 Lic. # 2229 |
08/23/2021 |
| Source Plasma | For further manufacturing of injectable products under License No. 2255 | 125751/0 | ABO Holdings, Inc. 2030 Main Street, Suite 1650 Irvine, CA 92614 Lic. # 2255 |
08/20/2021 |
| TicoVac Tick-Borne Encephalitis Vaccine |
Indicated for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older. | 125740/0 | Pfizer Ireland Pharmaceuticals 235 East 42nd Street 219/9/69 New York, NY 10017 Lic. # 2060 |
08/13/2021 |
| VAXNEUVANCE Pneumococcal 15-valent Conjugate Vaccine |
Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. | 125741/0 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. # 0002 |
07/16/2021 |
| Source Plasma | To manufacture Source Plasma prepared by plasmapheresis using the ---(b)(4)-------------------------------------- Collection System, with the anticoagulant (b)(4) Sodium Citrate Solution, collected from normal, non-immunized donors, andImmunoTek’s previously approved Standard Operating Procedures and Physician Substitute Program. | 125749/0 | LFB American Plasma, LLC 2200 Northeast Corporate Boulevard, Suite 210 Boca Raton, FL 33431 Lic. # 2254 |
06/25/2021 |
| StrataGraft Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat |
Indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). | 125730/0 | Stratatech Corporation 53 Frontage Road Shelbourne Building, Suite 300 Hampton, NJ 08827 Lic. # 2144 |
06/15/2021 |
| PREVNAR 20 Pneumococcal 20-valent Conjugate Vaccine |
Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older and the prevention of pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older. | 125731/0 | Wyeth Pharmaceuticals LLC 500 Arcola Road G4450 Collegeville, PA 19426 Lic. # 0003 |
06/08/2021 |
| RYPLAZIM plasminogen, human-tvmh |
Indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemi). | 125659/0 | Prometic Biotherapeutics, Inc. ---(b)(4)--- ----------------------- --------------------- --------------------- Lic. # 2065 |
06/04/2021 |
| ABECMA idecabtagene vicleucel |
Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. | 125736/0 | Celgene Corporation, a Bristol-Myers Squibb Company 86 Morris Ave. Summit, NJ 07901 Lic. # 2252 |
03/26/2021 |
| BREYANZI lisocabtagene maraleucel |
Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. | 125714/0 | Juno Therapeutics, Inc. 400 Dexter Avenue North Suite 1200 Seattle, WA 98109 Lic. # 2156 |
02/05/2021 |