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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 ApprovalsDevelopment & Approval Process (CBER) 2023 Biological License Application Approvals
  
  	
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    PrintThis 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.

2023 Biological License Application Approvals
	*Tradename/*Proper Name
			Indication for Use
			STN
			Manufacturer/
			License Number
			Approval Date***Alyglo***
			immune globulin intravenous, human-stwk
			Indicated for treatment of primary humoral immunodeficiency (PI) in adults.
			125743/0
			GC Biopharma Corp.
			------(b)(4)-------------------------------------
			-------------------------------
			Lic. # 2033
			12/15/2023***Casgevy***
			exagamglogene autotemcel (exa-cel)
			Indicated for treatment of sickle cell disease (SCD) in patients 12 years of age or older with recurrent vaso-occlusive crises (VOCs).
			125787/0
			Vertex Pharmaceuticals Inc
			50 Northern Avenue
			Boston, MA 02210
			Lic. # 2279
			12/08/2023***LYFGENIA***
			lovotibeglogene autotemcel
			Indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs).
			125788/0
			bluebird bio, Inc.
			455 Grand Union Boulevard
			Somerville, Massachusetts 02145
			Lic. # 2160
			12/08/2023***ADZYNMA***
			ADAMTS13, recombinant-krhn
			Indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP).
			125795/0
			Takeda Pharmaceuticals U.S.A., Inc.
			125 Binney Street
			Cambridge, MA 02142
			Lic. # 1898
			11/09/2023***IXCHIQ***
			Chikungunya Vaccine, Live
			Indicated for active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
			125777/0
			Valneva Austria GmbH
			Valneva USA, Inc.
			4550 Montgomery Avenue
			Bethesda, MD 20814
			Lic. # 1909
			11/09/2023***PENBRAYA***
			Meningococcal Groups A, B, C, W, and Y Vaccine
			Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. Meningococcal Groups A, B, C, W, and Y Vaccine is approved for use in individuals 10 through 25 years of age.
			125770/0
			Pfizer Ireland Pharmaceuticals
			Pfizer Inc.
			1 Pfizer Way
			190/004/4405
			Pearl River, NY 10965
			Lic. # 2060
			10/20/2023***Elecsys HTLV- I/II***
			Elecsys HTLV-I/II
			Intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.
			125792/0
			Roche Diagnostics
			9115 Hague Road
			Indianapolis, IN
			46250
			Lic. # 2305
			10/17/2023Source Plasma
			Indicated for further manufacturing of injectable and non-injectable products.
			125801/0
			DB Biologics LLC
			4101 Research Commons
			79 T.W. Alexander Drive
			Research Triangle Park, NC 27709
			Lic. # 2327
			09/13/2023***ABRYSVO***
			Respiratory Syncytial Virus Vaccine
			Indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
			125768/0
			Pfizer Inc.
			500 Arcola Road
			Collegeville, PA 19426
			Lic. # 2001
			08/21/2023***BALFAXAR***
			prothrombin complex concentrate, human-lans
			Indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.
			125776/0
			Octapharma Pharmazeutika Produktionsges.m.b.H.
			Octapharma USA, Inc.
			117 West Century Road
			Paramus, NJ 07652
			Lic. # 1646
			07/21/2023***CYFENDUS***
			Anthrax Vaccine Adsorbed, Adjuvanted
			Indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
			125761/0
			Emergent Product Development Gaithersburg Inc.
			300 Professional Drive
			Gaithersburg, MD 20879
			Lic. # 2089
			07/20/2023***ROCTAVIAN***
			valoctocogene roxaparvovec-rvox
			Valoctocogene roxaparvovec-rvox is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity <1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.
			125720/0
			BioMarin Pharmaceutical Inc.
			105 Digital Drive
			Novato, CA 94949
			Lic. # 1649
			06/29/2023***LANTIDRA***
			donislecel-jujn
			Indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
			125734/0
			CellTrans Inc.
			2201 W. Campbell Park Drive, Suite 23
			Chicago, IL 60612
			Lic. # 2213
			06/28/2023***ELEVIDYS***
			delandistrogene moxeparvovec-rokl
			Indicated for treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
			125781/0
			Sarepta Therapeutics, Inc.
			215 First Street
			Cambridge, MA 02142
			Lic. # 2308
			06/22/2023***Elecsys HIV Duo***
			Elecsys HIV Duo
			Elecsys HIV Duo is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.
			125778/0
			Roche Diagnostics
			9115 Hague Road
			Indianapolis, IN 46250
			Lic. # 2305
			06/13/2023***ABRYSVO***
			Respiratory Syncytial Virus Vaccine
			Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
			125769/0
			Pfizer Inc.
			500 Arcola Road
			Collegeville, PA 19426
			Lic. # 2001
			05/31/2023***VYJUVEK***
			beremagene geperpavec-svdt
			Indicated for treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
			125774/0
			Krystal Biotech, Inc.
			2100 Wharton Street, Suite 701
			Pittsburgh, PA 15203
			Lic. # 2301
			05/19/2023***AREXVY***
			Respiratory Syncytial Virus Vaccine, Adjuvanted
			Indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older.
			125775/0
			GlaxoSmithKline Biologicals
			14200 Shady Grove Road
			Rockville, MD 20850
			Lic. # 1617
			05/03/2023***VOWST***
			fecal microbiota spores, live-brpk
			To prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
			125757/0
			Seres Therapeutics, Inc.
			200 Sidney Street
			Cambridge, MA 02139
			Lic. # 2262
			04/26/2023***OMISIRGE***
			omidubicel-onlv
			Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
			125738/0
			Gamida Cell Ltd.
			116 Huntington Ave., 7th floor
			Boston, MA 02116
			Lic. # 2223
			04/17/2023Source Plasma
			Indicated for further manufacturing of injectable and non-injectable products.
			125790/0
			Clinical Research Technologies, Inc. (CRT)
			1068 Broadway
			El Cajon, CA 92021
			Lic. # 2316
			02/23/2023***ALTUVIIIO***
			antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
			Indicated for use in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding.
			125771/0
			Bioverativ Therapeutics, Inc.
			55 Corporate Drive
			Bridgewater, NJ 08807
			Lic. # 2078
			02/22/2023Source Plasma
			Indicated for further manufacturing of injectable products
			125762/0
			Join Parachute, LLC
			210 Barton Springs Drive, #550
			Austin, TX 78704
			Lic. # 2273
			01/25/2023Source Plasma
			Indicated for further manufacturing of injectable and noninjectable products
			125767/0
			Olgam Life LLC
			1104 Fulton Street
			Brooklyn, NY 11238
			Lic. # 2287
			01/19/2023Source Plasma
			Indicated for further manufacturing of injectable products
			125765/0
			Pelican Plasma
			8910 Linwood Avenue
			Shreveport, LA 71106
			Lic. # 2283
			01/17/2023

                                                                                  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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