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 In this section:

                Development & Approval Process (CBER)

Development & Approval Process (CBER)

                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          2023 Biological License Application Supplement Noteworthy ApprovalsDevelopment & Approval Process (CBER) 2023 Biological License Application Supplement Noteworthy Approvals
  
  	
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    PrintThis 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.

2023 Biological License Application Supplement Noteworthy Approvals
	*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

                                                                                  Content current as of:
      01/24/2024Development & Approval Process (CBER)

          
                        2023 Biological Approvals
          2022 Biological Approvals
          Biological Approvals by Year
          Expanded Access to Experimental Biologics
          Vaccine Development – 101


                        Biologics License Applications (BLA) Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Device Submissions for CBER-Regulated Products
          Labeling for CBER-Regulated Products
          Master Files for CBER-Regulated Products
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
          Formal Meetings for CBER-Regulated Products
 
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