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  1. Development & Approval Process (CBER)

2022 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.

2022 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
ROTARIX
Rotavirus Vaccine, Live, Oral
To include a porcine circovirus (PCV)-free liquid formulation of ROTARIX in an oral dosing applicator only presentation, manufactured at the ---(b)(4)--- Belgium location, and labeled and packaged at the -----(b)(4)----- location, and a squeezable tube presentation, manufactured, labeled and packaged at the -(b)(4)- Belgium location, for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants 6 weeks and up to 24 weeks of age. 125265/645 GlaxoSmithKline Biologicals
14200 Shady Grove Road
VR1500
Rockville, MD 20850-7464

Lic. # 1617
11/04/2022
MENVEO
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
To include a one-vial presentation of MENVEO manufactured at the GSK Vaccines facility S.R.L. in Sovicille, Italy, for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 10 through 55 years of age. 125300/778 GlaxoSmithKline Biologicals
14200 Shady Grove Road
VR1500
Rockville, MD 20850-7464

Lic. # 1617
10/14/2022
BOOSTRIX
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
To include immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. 125106/1469 GlaxoSmithKline Biologicals
14200 Shady Grove Road
VR1500
Rockville, MD 20850-7464

Lic. # 1617
10/7/2022
PREVNAR 20
Pneumococcal 20-valent Conjugate Vaccine
To update the labeling Package Insert to include results from study B7471004 “A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine (20vPnC) when Co-administered with Seasonal Inactivated Influenza Vaccine (SIIV) in Adults ≥ 65 Years of Age”. 125731/61 Wyeth Pharmaceuticals LLC
500 Arcola Road, G4450
Collegeville, PA 19426

Lic. # 0003
09/30/2022
REBINYN
Coagulation Factor IX (Recombinant) GlycoPEGylated
To expand the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hemophilia B. 125611/223 Novo Nordisk Inc
P.O. Box 846
800 Scudders Mill Road
Plainsboro, NJ 08536

Lic. # 1261
07/29/2022
QUADRACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
To update the Package Insert to include "Syncope" in Section 5 Warnings and Precautions and to include use of Quadracel in children whose previous diphtheria, tetanus, and pertussis (DTaP) vaccine doses have been with Vaxelis in Section 1 Indications and Usage. 125525/228 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada M2R 3T4

Lic. # 1726
07/21/2022
PENTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
To update the Package Insert to include "Syncope" in Section 5 Warnings and Precautions, to include information on mixed sequences of Pentacel with Quadracel and Pentacel with Vaxelis in Section 2 Dosage and Administration, and to include Pentacel administration to complete the 4-dose pertussis primary vaccination series following 3 doses of Vaxelis in Section 14 Clinical Studies. 125145/652 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada M2R 3T4

Lic. # 1726
07/21/2022
DAPTACEL
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
To update the Package Insert to include information on mixed sequences of Daptacel and Vaxelis in Section 2 Dosage and Administration, to include Daptacel administration to complete the 4-dose pertussis primary vaccination series following 3 doses of Vaxelis in Section 14 Clinical Studies, and to remove subsections 8.1 (Pregnancy) and 8.2 (Lactation) under the Use in Specific Populations section. 103666/5499 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada M2R 3T4

Lic. # 1726
07/21/2022
COMIRNATY
COVID-19 Vaccine, mRNA
To include use in adolescents 12 through 15 years of age for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 125742/45 BioNTech Manufacturing GmbH
Pfizer, Inc.
1 Pfizer Way 190/004/4405
Pearl River, NY 10965

Lic. # 2229
07/08/2022
BREYANZI
lisocabtagene maraleucel

To support two new indications for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large Bcell 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, who have:

• refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or

• refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age.

125714/90 Juno Therapeutics, Inc.
a Bristol-Myers Squibb Company
86 Morris Ave
Summit, NJ 07901

Lic. # 2156
06/24/2022
VAXNEUVANCE
Pneumococcal 15-valent Conjugate Vaccinel
To include results from 7 clinical studies (V114-008, V114-023, V114-024, V114-027, V114-029, V114-030, and V114-031) conducted in children 6 weeks through 17 years of age and to fulfill PREA PMRs #1, #2, #3, #4. 125741/6 Merck Sharp and Dohme Corp.
351 N.
Sumneytown Pike
North Wales, PA

Lic. # 0002
06/17/2022
KYMRIAH
Tisagenlecleucel
To add a new indication for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy, and to include a major modification to the approved Risk Evaluation and Mitigation Strategy (REMS), according to [21 CFR 601.41]. 125646/663 Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936

Lic. # 1244
05/27/2022
YESCARTA
axicabtagene ciloleucel
To add a new indication for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. 125643/394 Kite Pharma, Inc.
2400 Broadway
Santa Monica, CA 90404

Lic. # 2064
04/01/2022
VONVENDI
von Willebrand factor (Recombinant)
To update the US Prescribing Information to expand the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults diagnosed with severe Type 3 von Willebrand Disease receiving on-demand therapy 125577/412 Baxalta US Inc.
300 Shire Way
Lexington, MA 02421

Lic. # 2020
01/28/2022
 
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