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  1. Development & Approval Process (CBER)

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.

2021 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
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

 

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