2023 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 |
|---|---|---|---|---|
| YESCARTA axicabtagene ciloleucel |
To revise Section 14 CLINICAL STUDIES in the U.S. Prescribing Information to include the primary overall survival analysis data from study KTE-C19-107 (ZUMA-7). | 125643/524 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064 |
12/21/2023 |
| CARVYKTI ciltacabtagene autoleucel |
To supplement the Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act to revise Boxed Warning, Section 5 (Warnings and Precautions), Section 6 (Adverse Reactions), and Section 14 (Clinical Studies) of the U.S. Prescribing Information based on protocol-specified end-of-study analysis. | 125746/57 | Janssen Biotech, Inc. Janssen Research & Development, LLC 920 US Highway 202 Raritan, NJ 08869 Lic. # 1864 |
12/21/2023 |
| Bivigam Immune Globulin Intravenous (Human), 10% Liquid [BIVIGAM] |
To expand the primary humoral immunodeficiency (PI) indication to pediatric patients 2 years of age and older, update relevant sections with pediatric data from the pediatric studies, and ensure compliance with the Pregnancy and Lactation Labeling Rule (PLLR). | 125389/300 | ADMA Biologics, Inc. 5800 Park of Commerce Boulevard, N.W. Boca Raton, FL 33487 Lic. # 2019 |
12/08/2023 |
| COMIRNATY COVID-19 Vaccine, mRNA |
To include: use as a single dose for individuals 12 years of age and older, the 2023-2024 Formula, and all associated labeling revisions. | 125742/276 | BioNTech Manufacturing GmbH Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2229 |
09/11/2023 |
| SPIKEVAX COVID-19 Vaccine, mRNA |
To include: use in individuals 12 through 17 years of age, use as a single dose for individuals 12 years of age and older, the 2023-2024 Formula, manufacturing and quality control testing of 5-dose vials (0.1 mg/mL mRNA), and all associated labeling revisions. | 125752/68 | ModernaTX, Inc. 200 Technology Square Cambridge, MA 02139 Lic. # 2256 |
09/11/2023 |
| ERVEBO Ebola Zaire Vaccine, Live |
To extend the indication for use to include individuals 12 months of age and older. | 125690/55 | Merck Sharp & Dohme LLC 351 N. Sumneytown Pike P.O. Box 1000 North Wales, PA 19454 Lic. # 0002 |
07/27/2023 |
| DENGVAXIA Dengue Tetravalent Vaccine, Live |
To include safety and efficacy data that support the use of DENGVAXIA in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. | 125682/40 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. # 1725 |
06/30/2023 |
| BOOSTRIX Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
To include data on safety and the immune responses to BOOSTRIX when administered concomitantly with Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX). | 125106/1530 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 |
06/14/2023 |
| MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine |
To include safety and effectiveness data from clinical studies MET59 and MEQ66 in support of booster vaccination of individuals 13 years of age and older who are at continued risk for meningococcal disease if at least 3 years have elapsed since a prior dose of meningococcal (groups A, C, W, Y) conjugate vaccine, and vaccination following a prior dose of meningococcal polysaccharide vaccine if at least 3 years have elapsed since the prior dose of meningococcal polysaccharide vaccine. | 125701/128 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. # 1725 |
06/09/2023 |
| VAXNEUVANCE Pneumococcal 15-valent Conjugate Vaccine |
To include results from study V114-022 in the “Use in Specific Populations” section of the package insert, for pediatric and adult recipients of allogenic hematopoietic stem-cell transplant (allo-HSCT). | 125741/123 | Merck Sharp & Dohme LLC 351 N. Sumneytown Pike P.O. Box 1000 Suite UG2D-68 North Wales, PA 19454-2505 Lic. # 0002 |
05/25/2023 |
| SHINGRIX Zoster Vaccine Recombinant, Adjuvanted |
To include data on safety and the immune responses to SHINGRIX when administered concomitantly with Pneumococcal Vaccine Polyvalent (Pneumovax 23), Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PREVNAR 13) or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX), or following revaccination after vaccination with Zoster Vaccine Live (ZOSTAVAX). | 125614/700 | GlaxoSmithKline Biologicals 1400 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 |
05/22/2023 |
| GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant |
To include clinical data from the long-term follow-up study V503-002-20 in support of modifications to the package insert. | 125508/1434 | Merck Sharp & Dohme LLC 126 East Lincoln Ave. P.O. Box 2000 Rahway, NJ 07065 Lic. # 0002 |
04/28/2023 |
| COAGADEX Coagulation Factor X, (human) |
To expand the indication for perioperative management of bleeding to include patients with severe hereditary Factor X deficiency based on submission of the final study report for Study TEN06, intended to fulfill the Postmarketing Commitment #1. | 125506/164 | Bio Products Laboratory Limited 302 East Pettigrew Street, Suite C-190 Durham, NC 27701 Lic. # 1811 |
04/14/2023 |
| HYQVIA Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
To extend the indication of Primary Immunodeficiency Diseases to pediatric patients from 2 years of age ≤ 16 years of age. | 125402/818 | Baxalta US Inc. 650 East Kendall Street Cambridge, MA 02142 Lic. # 1898 |
04/07/2023 |
| M-M-R II Measles, Mumps, and Rubella Virus Vaccine Live |
To include safety and immunogenicity data that support the intramuscular route as an additional route of administration for M-M-R II, and associated product labeling changes. | 101069/5846 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. # 0002 |
02/27/2023 |
| VARIVAX Varicella Virus Vaccine Live |
To include safety and immunogenicity data that support the intramuscular route as an additional route of administration for VARIVAX, and associated product labeling changes. | 103552/6277 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. # 0002 |
02/27/2023 |
| ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
To include safety and immunogenicity data that support the intramuscular route as an additional route of administration for ProQuad, and associated product labeling changes. | 125108/1128 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike P.O. Box 1000 UG2D-68 North Wales, PA 19454 Lic. # 0002 |
02/27/2023 |
| DENGVAXIA Dengue Tetravalent Vaccine, Live |
To include data on the immune response to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel) when administered concomitantly with DENGVAXIA | 125682/37 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1725 |
01/25/2023 |
| ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract |
To include use in adolescents 12 through 17 years of age | 125592/157 | ALK-Abello A/S 135 Route 135 202/206 Bedminster, NJ 20879 Lic. # 1292 |
01/20/2023 |
| ADACEL 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. | 125111/904 | Sanofi Pasteur Limited 1755 Steele Avenue Toronto, Ontario Canada M2R 3T4 Lic. # 1726 |
01/09/2023 |