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.
| 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 |