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CBER Biologics

FDA has two centers that approve medicines. The drug center's approvals are in Drugs@FDA; the biologics center (CBER) licenses vaccines, gene therapies, blood products and allergy extracts, and those are not. This is CBER's list.

384 biologics licensed by FDA's Center for Biologics Evaluation and Research and listed in the Purple Book, newest Sep 17, 2026. These are the vaccines, gene and cell therapies, blood products and allergenics that Drugs@FDA, and so most approval trackers, leave out.

  • Licensed by CBER: 384
  • First licensed in the last 12 months: 12
  • Gene and cell therapies: 56
  • Newest: Sep 17, 2026

First Licensed per Year

By the earliest product approval listed for each licence, 2017 to Sep 17, 2026.

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

  • Full year
  • 2026 to date

By Type

Read from each product's proper name.

  • Blood or plasma product122
  • Vaccine105
  • Allergenic80
  • Gene or cell therapy56
  • Antitoxin or antivenom10
  • Skin test9
  • Microbiota2

Every CBER Licence

Newest first; sort by any column, or filter by product, company or type. Each BLA opens the Purple Book.
Sep 17, 2026Fayuvirebisufligene etisparvovec-hopfUltragenyx Pharmaceutical Inc.Gene or cell therapy125845
Aug 19, 2026GENGLYCOSpariglasgene brecaparvovec-opnrUltragenyx Pharmaceutical, Inc.Gene or cell therapy125858
Aug 6, 2026TUDRIQEVvusolimogene oderparepvec-wtpgReplimune, Inc.Gene or cell therapy125827
Aug 5, 2026flusiva,mflusivaInfluenza Vaccine, mRNAModernaTX, Inc.Vaccine125869
Jun 30, 2026tregziallogeneic regulatory T cell immunotherapy with HSPC and T cells-vldqOrca Biosystems Inc.Gene or cell therapy125868
Apr 23, 2026OTARMENIlunsotogene parvec-cwhaRegeneron Pharmaceuticals, Inc.Gene or cell therapy125874
Mar 26, 2026kresladimarnetegragene autotemcelRocket Pharmaceuticals IncGene or cell therapy125806
Dec 16, 2025FESILTYfibrinogen, humanchmtGrifols Therapeutics LLCBlood or plasma product125833
Dec 9, 2025waskyraetuvetidigene autotemcelFondazione Telethon EtsGene or cell therapy125846
Dec 3, 2025avance nerve graftacellular nerve allograft-arwxAxogen CorporationGene or cell therapy125816
Nov 24, 2025ITVISMAonasemnogene abeparvovec-brveNovartis Gene Therapies, Inc.Gene or cell therapy125856
Sep 26, 2025QIVIGYImmune Globulin Intravenous, Human-kthm, 10% SolutionKedrion, S.p.A.Blood or plasma product125822
Aug 14, 2025PAPZIMEOSzopapogene imadenovec-drbaPrecigen, Inc.Gene or cell therapy125832
May 30, 2025mnexspikeCOVID-19 Vaccine, mRNAModernaTX, Inc.Vaccine125835
May 16, 2025NUVAXOVIDCOVID-19 Vaccine, AdjuvantedSanofi Vaccines US Inc.Vaccine125817
Apr 28, 2025zevaskynPrademagene zamikeracelAbeona Therapeutics Inc.Gene or cell therapy125807
Mar 5, 2025enceltorevakinagene taroretcel-lweyNeurotech Pharmaceuticals Inc.Gene or cell therapy125798
Feb 14, 2025PENMENVYMeningococcal Groups A, B, C, W and Y VaccineGlaxoSmithKline BiologicalsVaccine125819
Feb 14, 2025VIMKUNYAChikungunya Vaccine, RecombinantBavarian Nordic A/SVaccine125820
Dec 19, 2024symvessacellular tissue engineered vessel-tyodHumacyte Global Inc.Gene or cell therapy125812
Dec 18, 2024ryoncilremestemcel-L-rkndMesoblast, Inc.Gene or cell therapy125706
Nov 21, 2024regenecyteHPC, Cord BloodStemCyte, Inc.Gene or cell therapy125764
Nov 13, 2024KEBILIDIeladocagene exuparvovec-tneqPTC TherapeuticsGene or cell therapy125722
Nov 8, 2024AucatzylObecabtagene autoleucelAutolus, Inc.Gene or cell therapy125813
Aug 1, 2024tecelraafamitresgene autoleucelUSWM CT, LLCGene or cell therapy125789
Jun 17, 2024CAPVAXIVEPneumococcal 21-valent Conjugate VaccineMerck Sharp & Dohme LLCVaccine125814
Jun 13, 2024YIMMUGOimmune globulin intravenous, human-diraBiotest AGBlood or plasma product125810
May 31, 2024mresviaRespiratory Syncytial Virus VaccineModernaTX, Inc.Vaccine125796
Apr 25, 2024BEQVEZfidanacogene elaparvovec-dzktPfizer Inc.Gene or cell therapy125786
Mar 18, 2024Lenmeldyatidarsagene autotemcelOrchard Therapeutics (Europe) Ltd.Gene or cell therapy125758
Feb 16, 2024AMTAGVILifileucelIovance Biotherapeutics, Inc.Gene or cell therapy125773
Dec 15, 2023Alygloimmune globulin intravenous, human-stwkGC Biopharma Corp.Blood or plasma product125743
Dec 8, 2023CasgevyExagamglogene autotemcelVertex Pharmaceuticals IncGene or cell therapy125787
Dec 8, 2023LYFGENIAlovotibeglogene autotemcelGenetix Biotherapeutics Inc.Gene or cell therapy125788
Nov 9, 2023IXCHIQChikungunya Vaccine, LiveValneva Austria GmbHVaccine125777
Nov 9, 2023ADZYNMAADAMTS13, recombinant-krhnTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125795
Oct 20, 2023PENBRAYAMeningococcal Groups A, B, C, W, and Y VaccinePfizer Ireland Pharmaceuticals Unlimited CompanyVaccine125770
Jul 21, 2023BalfaxarProthrombin complex concentrate, human-lansOctapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125776
Jul 20, 2023CYFENDUSAnthrax Vaccine Adsorbed, AdjuvantedEmergent Product Development Gaithersburg, Inc.Vaccine125761
Jun 29, 2023Roctavianvaloctocogene roxaparvovec-rvoxBiomarin Pharmaceutical Inc.Gene or cell therapy125720
Jun 28, 2023Lantidradonislecel-jujnCellTrans Inc.Gene or cell therapy125734
Jun 22, 2023ELEVIDYSdelandistrogene moxeparvovec-roklSarepta Therapeutics, Inc.Gene or cell therapy125781
May 31, 2023AbrysvoRespiratory Syncytial Virus VaccinePfizer Inc.Vaccine125769
May 19, 2023VYJUVEKberemagene geperpavec-svdtKrystal Biotech, Inc.Gene or cell therapy125774
May 3, 2023ArexvyRespiratory Syncytial Virus Vaccine, AdjuvantedGlaxoSmithKline BiologicalsVaccine125775
Apr 26, 2023Vowstfecal microbiota spores, live-brpkAimmune Therapeutics, Inc.Microbiota125757
Apr 17, 2023OMISIRGEomidubicel-onlvGamida Cell Ltd.Gene or cell therapy125738
Feb 22, 2023ALTUVIIIOantihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtlBioverativ Therapeutics, Inc.Blood or plasma product125771
Dec 16, 2022Adstiladrinnadofaragene firadenovec-vncgFerring Pharmaceuticals A/SGene or cell therapy125700
Nov 30, 2022Rebyotafecal microbiota, live-jslmFerring Pharmaceuticals Inc.Microbiota125739
Nov 22, 2022Hemgenixetranacogene dezaparvovec-drlbCSL Behring LLCGene or cell therapy125772
Sep 16, 2022Skysonaelivaldogene autotemcelGenetix Biotherapeutics Inc.Gene or cell therapy125755
Aug 17, 2022Zynteglobetibeglogene autotemcelGenetix Biotherapeutics Inc.Gene or cell therapy125717
Jun 3, 2022PRIORIXMeasles, Mumps and Rubella Vaccine LiveGlaxoSmithKline BiologicalsVaccine125748
Feb 28, 2022Carvykticiltacabtagene autoleucelJanssen Biotech, Inc.Gene or cell therapy125746
Jan 31, 2022SpikevaxCOVID-19 Vaccine, mRNAModernaTX, Inc.Vaccine125752
Nov 30, 2021PrehevbrioHepatitis B Vaccine (Recombinant)VBI Vaccines (Delaware), Inc.Vaccine125737
Oct 8, 2021Rethymicallogeneic processed thymus tissue-agdcSumitomo Pharma America, Inc.Gene or cell therapy125685
Aug 23, 2021ComirnatyCOVID-19 Vaccine, mRNABioNTech Manufacturing GmbHVaccine125742
Aug 13, 2021TicovacTick-Borne Encephalitis VaccinePfizer Ireland Pharmaceuticals Unlimited CompanyVaccine125740
Jul 16, 2021VaxneuvancePneumococcal 15-valent Conjugate VaccineMerck Sharp & Dohme LLCVaccine125741
Jun 15, 2021StrataGraftAllogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsatStratatech CorporationGene or cell therapy125730
Jun 8, 2021Prevnar 20Pneumococcal 20-valent Conjugate VaccineWyeth Pharmaceuticals LLCVaccine125731
Jun 4, 2021Ryplazimplasminogen, human-tvmhKedrion Biopharma Inc.Blood or plasma product125659
Mar 3, 2021Abecmaidecabtagene vicleucelCelgene Corporation, a Bristol-Myers Squibb CompanyGene or cell therapy125736
Feb 5, 2021Breyanzilisocabtagene maraleucelJuno Therapeutics, Inc. a Bristol Myer-Squibb CompanyGene or cell therapy125714
Jul 24, 2020TecartusBrexucabtagene AutoleucelKite Pharma, Inc.Gene or cell therapy125703
Apr 23, 2020MenquadfiMeningococcal (Groups A, C, Y, W) Conjugate VaccineSanofi Vaccines US Inc.Vaccine125701
Apr 1, 2020Sevenfactcoagulation factor VIIa (recombinant)-jncwLaboratoire Francais du Fractionnement et des Biotechnologies S.A.Blood or plasma product125641
Jan 31, 2020AudenzInfluenza A (H5N1) Monovalent Vaccine, AdjuvantedSeqirus Inc.Vaccine125692
Jan 31, 2020PalforziaPeanut (Arachis hypogaea) Allergen Powder-dnfpGreer Laboratories, Inc.Allergenic125696
Dec 19, 2019ErveboEbola Zaire Vaccine, LiveMerck Sharp & Dohme LLCVaccine125690
Sep 24, 2019JynneosSmallpox and Mpox Vaccine, Live, Non-replicatingBavarian Nordic A/SVaccine125678
Jul 3, 2019Xembifyimmune globulin subcutaneous, human-klhwGrifols Therapeutics LLCBlood or plasma product125683
May 24, 2019Zolgensmaonasemnogene abeparvovec-xioiNovartis Gene Therapies, Inc.Gene or cell therapy125694
May 1, 2019DengvaxiaDengue Tetravalent Vaccine, LiveSanofi Vaccines US Inc.Vaccine125682
Apr 1, 2019AscenivImmune Globulin Intravenous, Human-slraADMA Biologics, Inc.Blood or plasma product125590
Feb 19, 2019EsperoctAntihemophilic Factor (Recombinant), GlycoPEGylated-exeiNovo Nordisk Inc.Blood or plasma product125671
Dec 21, 2018VaxelisDiphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B VaccineMSP Vaccine CompanyVaccine125563
Dec 12, 2018CutaquigImmune Globulin Subcutaneous (Human)-hippOctapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125668
Aug 29, 2018JiviAntihemophilic factor (recombinant), PEGylated-auclBayer HealthCare LLCBlood or plasma product125661
Aug 2, 2018PanzygaImmune Globulin Intravenous (Human)-ifasOctapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125587
Jun 21, 2018N/AHematopoietic Progenitor Cells, Cord (HPC-C)MD Anderson Cord Blood BankGene or cell therapy125657
Jun 19, 2018AlbuminexAlbumin (Human)-kjdaBio Products Laboratory LimitedBlood or plasma product125644
May 3, 2018AndexxaCoagulation Factor Xa (Recombinant), Inactivated-zhzoAstraZeneca ABBlood or plasma product125586
Dec 19, 2017LuxturnaVoretigene NeparvovecSpark Therapeutics, Inc.Gene or cell therapy125610
Nov 9, 2017Heplisav-BHepatitis B Vaccine (Recombinant), AdjuvantedDynavax Technologies CorporationVaccine125428
Nov 1, 2017VistasealFibrin Sealant (Human)Instituto Grifols, S.A.Blood or plasma product125640
Oct 20, 2017ShingrixZoster Vaccine Recombinant, AdjuvantedGlaxoSmithKline BiologicalsVaccine125614
Oct 18, 2017Yescartaaxicabtagene ciloleucelKite Pharma, Inc.Gene or cell therapy125643
Aug 30, 2017KymriahtisagenlecleucelNovartis Pharmaceuticals CorporationGene or cell therapy125646
Aug 23, 2017KedrabRabies Immune Globulin (Human)Kamada Ltd.Blood or plasma product125613
Jun 22, 2017HaegardaC1 Esterase Inhibitor Subcutaneous (Human)CSL Behring GmbHBlood or plasma product125606
Jun 7, 2017FibrygaFibrinogen (Human)Octapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125612
May 31, 2017RebinynCoagulation Factor IX (Recombinant), GlycoPEGylatedNovo Nordisk Inc.Blood or plasma product125611
Mar 3, 2017hudquzco rubber panel,rubber panel t.r.u.e. testRubber Panel Thin-Layer Rapid Use Epicutaneous Patch TestSmartPractice Denmark ApSSkin test125579
Mar 1, 2017OdactraHouse Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen ExtractALK - Abello A/SAllergenic125592
Dec 13, 2016Maciautologous cultured chondrocytes on porcine collagen membraneVericel CorporationGene or cell therapy125603
Sep 13, 2016CuvitruImmune Globulin Subcutaneous (Human), 20% SolutionTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125596
Sep 1, 2016ClevecordHPC, Cord BloodCleveland Cord Blood CenterGene or cell therapy125594
Jun 10, 2016VaxchoraCholera Vaccine, Live, OralBavarian Nordic A/SVaccine125597
May 25, 2016AfstylaAntihemophilic Factor (Recombinant), Single ChainCSL Behring Lengnau AGBlood or plasma product125591
Mar 16, 2016KovaltryAntihemophilic Factor (Recombinant), Full LengthBayer HealthCare LLCBlood or plasma product125574
Mar 4, 2016IdelvionCoagulation Factor IX (Recombinant), Albumin Fusion ProteinCSL Behring Lengnau AGBlood or plasma product125582
Jan 28, 2016N/AHPC, Cord BloodBloodworksGene or cell therapy125585
Dec 8, 2015Vonvendivon Willebrand factor (Recombinant)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125577
Nov 24, 2015FluadInfluenza Vaccine, AdjuvantedSeqirus Inc.Vaccine125510
Nov 13, 2015AdynovateAntihemophilic Factor (Recombinant), PEGylatedTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125566
Oct 27, 2015ImlygicTalimogene laherparepvecAmgen Inc.Gene or cell therapy125518
Oct 20, 2015CoagadexCoagulation Factor X (Human)Bio Products Laboratory LimitedBlood or plasma product125506
Sep 4, 2015NuwiqAntihemophilic Factor (Recombinant)Octapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125555
May 6, 2015AnavipCrotalidae Immune F(ab')2 (Equine)Rare Disease Therapeutics, Inc. (RDT)Antitoxin or antivenom125488
Apr 30, 2015RaplixaFibrin Sealant (Human)Mallinckrodt Pharma IP Trading DACBlood or plasma product125523
Apr 29, 2015IxinityCoagulation Factor IX (Recombinant)Medexus Pharma, Inc.Blood or plasma product125426
Mar 24, 2015QuadracelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi Vaccines Canada Ltd.Vaccine125525
Mar 24, 2015AnthrasilAnthrax Immune Globulin Intravenous (Human)Emergent BioSolutions Canada Inc.Blood or plasma product125562
Jan 23, 2015BexseroMeningococcal Group B VaccineGlaxoSmithKline BiologicalsVaccine125546
Dec 10, 2014Gardasil 9Human Papillomavirus 9-valent Vaccine, RecombinantMerck Sharp & Dohme LLCVaccine125508
Oct 29, 2014TrumenbaMeningococcal Group B VaccineWyeth Pharmaceuticals LLCVaccine125549
Oct 23, 2014ObizurAntihemophilic Factor (Recombinant), Porcine SequenceTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125512
Sep 12, 2014HyqviaImmune Globulin Infusion (Human), 10% with Recombinant Human HyaluronidaseTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125402
Jul 16, 2014RuconestC1 Esterase Inhibitor (Recombinant)Pharming Americas BVBlood or plasma product125495
Jun 6, 2014EloctateAntihemophilic Factor (Recombinant), Fc Fusion proteinBioverativ Therapeutics, Inc.Blood or plasma product125487
Apr 17, 2014RagwitekShort Ragweed Pollen Allergen ExtractALK - Abello A/SAllergenic125478
Apr 11, 2014GrastekTimothy Grass Pollen Allergen ExtractALK - Abello A/SAllergenic125473
Apr 1, 2014OralairSweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen ExtractStallergenes, SASAllergenic125471
Mar 28, 2014AlprolixCoagulation Factor IX (Recombinant), Fc Fusion ProteinBioverativ Therapeutics, Inc.Blood or plasma product125444
Dec 23, 2013TrettenCoagulation Factor XIII A-Subunit (Recombinant)Novo Nordisk Inc.Blood or plasma product125398
Nov 22, 2013ArepanrixInfluenza A [H5] Monovalent Vaccine, AdjuvantedID Biomedical Corporation of QuebecVaccine125419
Oct 15, 2013NovoeightAntihemophilic Factor (Recombinant)Novo Nordisk Inc.Blood or plasma product125466
Jun 26, 2013RixubisCoagulation Factor IX (Recombinant)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125446
Jun 13, 2013CordcyteHPC, Cord BloodLifeSouth Community Blood Centers, Inc.Gene or cell therapy125432
May 30, 2013AllocordHPC, Cord BloodSSM Cardinal Glennon Children's Medical CenterGene or cell therapy125413
Apr 29, 2013KcentraProthrombin Complex Concentrate (Human)CSL Behring GmbHBlood or plasma product125421
Mar 22, 2013BatBotulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)Emergent BioSolutions Canada Inc.Antitoxin or antivenom125462
Jan 17, 2013OctaplasPooled Plasma (Human), Solvent/Detergent TreatedOctapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125416
Jan 16, 2013FlublokInfluenza VaccineProtein Sciences CorporationVaccine125285
Dec 20, 2012VarizigVaricella Zoster Immune Globulin (Human)Kamada Ltd.Blood or plasma product125430
Dec 19, 2012BivigamImmune Globulin Intravenous (Human)ADMA Biologics, Inc.Blood or plasma product125389
Dec 5, 2012EvarrestFibrin Sealant PatchEthicon, Inc.Blood or plasma product125392
Nov 20, 2012Flucelvax, Flucelvax QuadrivalentInfluenza VaccineSeqirus Inc.Vaccine125408
Oct 4, 2012DucordHPC, Cord BloodDuke University School of MedicineGene or cell therapy125407
Jun 14, 2012MENHIBRIXMeningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate VaccineGlaxoSmithKline BiologicalsVaccine125363
May 24, 2012N/AHPC, Cord BloodClinimmune LabsGene or cell therapy125391
Mar 9, 2012GintuitAllogeneic Cultured Keratinocytes and Fibroblasts in Bovine CollagenOrganogenesis, Inc.Gene or cell therapy125400
Nov 10, 2011HemacordHematopoietic Progenitor Cells, Cord (HPC-C)New York Blood Center, Inc.Gene or cell therapy125397
Aug 3, 2011AnascorpCentruroides (Scorpion) Immune F(ab')2 (Equine) InjectionRare Disease Therapeutics, Inc. (RDT)Antitoxin or antivenom125335
Jul 29, 2011SpherusolCoccidioides immitis Spherule-Derived Skin Test AntigenNielsen Bioscience, IncSkin test125354
Jun 21, 2011LavivAzficel-TFibrocell Technologies, Inc.Gene or cell therapy125348
Jun 3, 2011KedbuminAlbumin (Human)Kedrion Biopharma Inc.Blood or plasma product125384
Mar 16, 2011N/AAdenovirus Type 4 and Type 7 Vaccine, Live, OralTeva Women's Health, Inc.Vaccine125296
Feb 17, 2011CorifactFactor XIII Concentrate (Human)CSL Behring GmbHBlood or plasma product125385
Dec 20, 2010Wilatevon Willebrand Factor/Coagulation Factor VIII Complex (Human)Octapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125251
Jul 1, 2010GlassiaAlpha-1-Proteinase Inhibitor (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125325
Apr 29, 2010Provengesipuleucel-TDendreon Pharmaceuticals LLCGene or cell therapy125197
Apr 5, 2010TachosilFibrin Sealant PatchCorza Medical GmbHBlood or plasma product125351
Mar 4, 2010HizentraImmune Globulin Subcutaneous (Human), 20% LiquidCSL Behring AGBlood or plasma product125350
Feb 24, 2010Prevnar 13Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)Wyeth Pharmaceuticals LLCVaccine125324
Feb 19, 2010MenveoMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineGlaxoSmithKline BiologicalsVaccine125300
Nov 27, 2009AgrifluInfluenza Virus VaccineSeqirus Inc.Vaccine125297
Oct 16, 2009CervarixHuman Papillomavirus Bivalent (Types 16 and 18) Vaccine, RecombinantGlaxoSmithKline BiologicalsVaccine125259
Oct 9, 2009BerinertC1 Esterase Inhibitor (Human)CSL Behring GmbHBlood or plasma product125287
Sep 17, 2009GammaplexImmune Globulin Intravenous (Human)Bio Products Laboratory LimitedBlood or plasma product125329
Aug 19, 2009HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)GlaxoSmithKline BiologicalsVaccine125347
Mar 30, 2009IxiaroJapanese Encephalitis Vaccine, Inactivated, AdsorbedValneva Austria GmbHVaccine125280
Feb 6, 2009AtrynAntithrombin (Recombinant)rEVO Biologics, Inc.Blood or plasma product125284
Jan 16, 2009RiastapFibrinogen Concentrate (Human)CSL Behring GmbHBlood or plasma product125317
Oct 10, 2008CinryzeC1 Esterase Inhibitor (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125267
Jun 24, 2008KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineGlaxoSmithKline BiologicalsVaccine125260
Jun 20, 2008PentacelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccineSanofi Vaccines Canada Ltd.Vaccine125145
Apr 3, 2008RotarixRotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsVaccine125265
Mar 19, 2008ArtissFibrin Sealant (Human)Baxter Healthcare CorporationBlood or plasma product125266
Feb 21, 2008Xyntha, Xyntha SolofuseAntihemophilic Factor (Recombinant), Plasma/Albumin FreeWyeth Pharmaceuticals LLCBlood or plasma product125264
Jan 17, 2008RecothromThrombin topical (Recombinant)Baxter Healthcare CorporationBlood or plasma product125248
Sep 28, 2007Afluria, Afluria QuadrivalentInfluenza VaccineSeqirus Pty Ltd.Vaccine125254
Aug 31, 2007Acam2000Smallpox (Vaccinia) Vaccine, LiveEmergent Product Development Gaithersburg, Inc.Vaccine125158
Aug 27, 2007EvithromThrombin, Topical (Human)Omrix Biopharmaceuticals LtdBlood or plasma product125247
Jul 26, 2007PrivigenImmune Globulin Intravenous (Human), 10% LiquidCSL Behring AGBlood or plasma product125201
Apr 17, 2007N/AInfluenza Virus Vaccine, H5N1Sanofi Vaccines US Inc.Vaccine125244
Mar 30, 2007CeprotinProtein C Concentrate (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125234
Oct 17, 2006N/AAlbumin (Human)Octapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125154
Oct 5, 2006Flulaval, Flulaval QuadrivalentInfluenza VaccineID Biomedical Corporation of QuebecVaccine125163
Jun 8, 2006GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, RecombinantMerck Sharp & Dohme LLCVaccine125126
May 25, 2006ZostavaxZoster Vaccine LiveMerck Sharp & Dohme LLCVaccine125123
Feb 3, 2006RotateqRotavirus Vaccine, Live, Oral, PentavalentMerck Sharp & Dohme LLCVaccine125122
Jan 27, 2006Hepagam BHepatitis B Immune Globulin (Human)Kamada Ltd.Blood or plasma product125035
Jan 9, 2006VivaglobinImmune Globulin Subcutaneous (Human)CSL Behring GmbHBlood or plasma product125115
Sep 6, 2005ProquadMeasles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine125108
Aug 31, 2005Fluarix, Fluarix QuadrivalentInfluenza VaccineGlaxoSmithKline BiologicalsVaccine125127
Jun 10, 2005AdacelTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedSanofi Vaccines Canada Ltd.Vaccine125111
May 3, 2005BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedGlaxoSmithKline BiologicalsVaccine125106
May 2, 2005Cnj-016Vaccinia Immune Globulin Intravenous (Human)Emergent BioSolutions Canada Inc.Blood or plasma product125109
Apr 27, 2005Gammagard LiquidImmune Globulin Infusion (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125105
Jan 14, 2005MenactraMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineSanofi Vaccines US Inc.Vaccine125089
May 21, 2004OctagamImmune Globulin Intravenous (Human)Octapharma Pharmazeutika Produktionsges.m.b.H.Blood or plasma product125062
Feb 12, 2004RhophylacRho(D) Immune Globulin Intravenous (Human)CSL Behring AGBlood or plasma product125070
Dec 15, 2003Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)Instituto Grifols, S.A.Blood or plasma product125077
Nov 3, 2003TenivacTetanus and Diphtheria Toxoids AdsorbedSanofi Vaccines Canada Ltd.Vaccine103171
Oct 23, 2003BabyBigBotulism Immune Globulin Intravenous (Human)California Department of Public Health (CDPH)Blood or plasma product125034
Aug 27, 2003Gammaked, Gamunex-CImmune Globulin Injection (Human) 10% Caprylate/Chromatography PurifiedGrifols Therapeutics LLCBlood or plasma product125046
Jul 25, 2003AdvateAntihemophilic Factor (Recombinant), Plasma/Albumin Free MethodTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125063
Jul 8, 2003ZemairaAlpha-1-Proteinase Inhibitor (Human)CSL Behring LLCBlood or plasma product125078
Jun 17, 2003Flumist, Flumist QuadInfluenza Vaccine Live, IntranasalMedImmune, LLCVaccine125020
May 14, 2003Monoclate, Monoclate-PAntihemophilic Factor (Human)CSL Behring LLCBlood or plasma product103953
Mar 21, 2003Crosseal, EvicelFibrin Sealant (Human)Omrix Biopharmaceuticals LtdBlood or plasma product125010
Dec 23, 2002Aralast, Aralast NpAlpha-1-Proteinase Inhibitor (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product125039
Dec 13, 2002PediarixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus VaccineGlaxoSmithKline BiologicalsVaccine103907
Aug 20, 2002Helixate Fs, Kogenate, Kogenate FsAntihemophilic Factor (Recombinant)Bayer HealthCare LLCBlood or plasma product103332
May 14, 2002DaptacelDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedSanofi Vaccines Canada Ltd.Vaccine103666
Oct 23, 2001Nabi-HBHepatitis B Immune Globulin (Human)ADMA Biologics, Inc.Blood or plasma product103945
Aug 31, 2001DigifabDigoxin Immune Fab (Ovine)Salvagenix Inc.Antitoxin or antivenom103910
Jun 27, 2001RefactoAntihemophilic Factor (Recombinant)Wyeth Pharmaceuticals LLCBlood or plasma product103779
May 11, 2001TwinrixHepatitis A & Hepatitis B (Recombinant) VaccineGlaxoSmithKline BiologicalsVaccine103850
Mar 14, 2001Hemofil MAntihemophilic Factor (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product101448
Mar 6, 2001ImogamRabies Immune Globulin (Human)Sanofi Winthrop IndustrieBlood or plasma product103932
Oct 2, 2000CrofabCrotalidae Polyvalent Immune Fab (Ovine)BTG International Inc.Antitoxin or antivenom103788
Jul 27, 2000Carimune, Carimune Nf, Panglobulin, SandoglobulinImmune Globulin Intravenous (Human)CSL Behring AGBlood or plasma product102367
Apr 11, 2000Humate-PAntihemophilic Factor/von Willebrand Factor Complex (Human)CSL Behring GmbHBlood or plasma product103960
Mar 17, 2000Albuminar, Albuminar-20, Albuminar-25, Albuminar-5Albumin (Human)CSL Behring LLCBlood or plasma product103955
Mar 17, 2000gammar i.v.,gammar-p i.v.Immune Globulin Intravenous (Human)CSL Behring LLCBlood or plasma product103956
Mar 17, 2000MononineCoagulation Factor IX (Human)CSL Behring LLCBlood or plasma product103957
Feb 24, 2000N/ABotulism Antitoxin Bivalent (Equine) Types A and B.Sanofi Vaccines Canada Ltd.Antitoxin or antivenom103937
Feb 24, 2000PoliovaxPoliovirus Vaccine Inactivated (Human Diploid Cell)Sanofi Vaccines Canada Ltd.Vaccine103940
Feb 24, 2000TubersolTuberculin, Purified Protein DerivativeSanofi Vaccines Canada Ltd.Skin test103941
Feb 24, 2000MycobaxBCG VaccineSanofi Vaccines Canada Ltd.Vaccine103942
Feb 24, 2000TheraCysBCG LiveSanofi Vaccines Canada Ltd.Vaccine103943
Feb 24, 2000N/ADiphtheria & Tetanus Toxoids AdsorbedSanofi Vaccines Canada Ltd.Vaccine103944
Feb 17, 2000prevnarPneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)Wyeth Pharmaceuticals LLCVaccine103905
Feb 4, 2000IpolPoliovirus Vaccine InactivatedSanofi Winthrop IndustrieVaccine103930
Feb 4, 2000Imovax RabiesRabies VaccineSanofi Winthrop IndustrieVaccine103931
Feb 4, 2000Acthib,OmnihibHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Sanofi Winthrop IndustrieVaccine103935
Feb 4, 2000Typhim ViTyphoid Vi Polysaccharide VaccineSanofi Winthrop IndustrieVaccine103936
Dec 9, 1999N/ATetanus Toxoid AdsorbedSanofi Vaccines US Inc.Vaccine103913
Dec 9, 1999Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus VaccineSanofi Vaccines US Inc.Vaccine103914
Dec 9, 1999Yf-VaxYellow Fever VaccineSanofi Vaccines US Inc.Vaccine103915
Dec 9, 1999N/ADiphtheria & Tetanus Toxoids AdsorbedSanofi Vaccines US Inc.Vaccine103919
Dec 9, 1999N/ATetanus and Diphtheria Toxoids AdsorbedSanofi Vaccines US Inc.Vaccine103921
Dec 9, 1999TripediaDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedSanofi Vaccines US Inc.Vaccine103922
Dec 9, 1999Menomune-CMeningococcal Polysaccharide Vaccine, Group CSanofi Vaccines US Inc.Vaccine103923
Dec 9, 1999Menomune-AMeningococcal Polysaccharide Vaccine, Group ASanofi Vaccines US Inc.Vaccine103924
Dec 9, 1999Menomune-A/CMeningococcal Polysaccharide Vaccine, Groups A and C CombinedSanofi Vaccines US Inc.Vaccine103925
Dec 9, 1999MenomuneMeningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 CombinedSanofi Vaccines US Inc.Vaccine103926
May 19, 1999ThymoglobulinAnti-thymocyte Globulin (Rabbit)Genzyme CorporationBlood or plasma product103869
Mar 25, 1999Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)Novo Nordisk Inc.Blood or plasma product103665
Nov 12, 1998BiorabRabies Vaccine AdsorbedEmergent BioDefense Operations Lansing LLCVaccine103820
Nov 12, 1998BiothraxAnthrax Vaccine AdsorbedEmergent BioDefense Operations Lansing LLCVaccine103821
Nov 3, 1998FluvirinInfluenza Virus VaccineSeqirus Vaccines LimitedVaccine103837
May 1, 1998TisseelFibrin Sealant (Tisseel)Baxter Healthcare CorporationBlood or plasma product103980
Apr 23, 1998Micrhogam, RhogamRho(D) Immune Globulin (Human)Kedrion Biopharma Inc.Blood or plasma product103777
Apr 20, 1998AplisolTuberculin, Purified Protein DerivativeEndo Operations LimitedSkin test103782
Oct 20, 1997RabavertRabies VaccineBavarian Nordic A/SVaccine103334
Aug 22, 1997Carticel Sm ServiceAutologous Cultured ChondrocytesVericel CorporationGene or cell therapy103661
Aug 15, 1997T.R.U.E. TestThin-Layer Rapid Use Epicutaneous Patch TestSmartPractice Denmark ApSSkin test103738
Feb 11, 1997BenefixCoagulation Factor IX (Recombinant)Wyeth Pharmaceuticals LLCBlood or plasma product103677
Jan 29, 1997InfanrixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedGlaxoSmithKline BiologicalsVaccine103647
Dec 4, 1996AtgamLymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine)Pharmacia & Upjohn Company LLCBlood or plasma product103676
Oct 2, 1996COMVAXHaemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) VaccineMerck Sharp & Dohme LLCVaccine103623
Apr 2, 1996Winrho Sd, Winrho Sdf Liquid, Winrho Sdf LyophilizedRho(D) Immune Globulin Intravenous (Human)Kamada Ltd.Blood or plasma product103649
Mar 29, 1996VaqtaHepatitis A Vaccine InactivatedMerck Sharp & Dohme LLCVaccine103606
Nov 27, 1995CandinCandida albicans Skin Test Antigen for Cellular HypersensitivityNielsen Bioscience, IncSkin test103257
Mar 17, 1995VarivaxVaricella Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine103552
Feb 22, 1995HavrixHepatitis A VaccineGlaxoSmithKline BiologicalsVaccine103475
Feb 17, 1995Human Albumin GrifolsAlbumin (Human)Instituto Grifols, S.A.Blood or plasma product103352
Oct 5, 1994N/APlague VaccineGreer Laboratories, Inc.Vaccine103569
Dec 10, 1992Bioclate (Armour), RecombinateAntihemophilic Factor (Recombinant)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product103375
Feb 14, 1992N/APositive Skin Test Control-HistamineNielsen Bioscience, IncSkin test103317
Dec 30, 1991Thrombate IiiAntithrombin III (Human)Grifols Therapeutics LLCBlood or plasma product103196
Oct 8, 1991PharmalgenVenoms, Honey Bee VenomALK - Abello A/SAllergenic103969
Oct 8, 1991PharmalgenVenoms, Mixed Vespid Venom ProteinALK - Abello A/SAllergenic103970
Oct 8, 1991PharmalgenVenoms, Wasp Venom ProteinALK - Abello A/SAllergenic103971
Oct 8, 1991PharmalgenVenoms, White Faced Hornet Venom ProteinALK - Abello A/SAllergenic103972
Oct 8, 1991PharmalgenVenoms, Yellow Hornet Venom ProteinALK - Abello A/SAllergenic103973
Oct 8, 1991PharmalgenVenoms, Yellow Jacket Venom ProteinALK - Abello A/SAllergenic103974
Dec 31, 1990Alphanine, Alphanine Hp, Alphanine SdCoagulation Factor IX (Human)Grifols Biologicals LLCBlood or plasma product103249
Apr 17, 1990CytogamCytomegalovirus Immune Globulin Intravenous (Human)Kamada Ltd.Blood or plasma product103189
Dec 20, 1989PedvaxhibHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)Merck Sharp & Dohme LLCVaccine103237
Dec 15, 1989VivotifTyphoid Vaccine Live Oral Ty21aBavarian Nordic A/SVaccine103123
Aug 28, 1989Engerix-BHepatitis B Vaccine (Recombinant)GlaxoSmithKline BiologicalsVaccine103239
Jun 21, 1989Tice BcgBCG LiveMerck Teknika LLCVaccine102821
Jun 21, 1989N/ABCG VaccineMerck Teknika LLCVaccine103050
Dec 2, 1987prolastin,prolastin-c,prolastin-c liquidAlpha-1-Proteinase Inhibitor (Human)Grifols Therapeutics LLCBlood or plasma product103174
Jul 23, 1986Recombivax, Recombivax HbHepatitis B Vaccine (Recombinant)Merck Sharp & Dohme LLCVaccine101066
Apr 22, 1986DigibindDigoxin Immune Fab (Ovine)Wellcome Foundation Limited Wellcome Research LaboratoriesAntitoxin or antivenom103141
Feb 18, 1986Gammagard, Gammagard S/D, IveegamImmune Globulin Intravenous (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product103133
Feb 3, 1986Thrombin-Jmi, ThrombocollThrombin, Topical (Bovine)GenTrac, Inc.Blood or plasma product102865
Jul 20, 1983PanhematinHemin for InjectionRecordati Rare Diseases, Inc.Blood or plasma product101246
Sep 11, 1981GamimuneImmune Globulin Intravenous (Human)Grifols Therapeutics LLCBlood or plasma product101147
Jul 20, 1981Profilnine, Profilnine Hp, Profilnine Ht, Profilnine SdFactor IX ComplexGrifols Biologicals LLCBlood or plasma product102476
Dec 21, 1979Autoplex, Feiba Nf, Feiba VhAnti-Inhibitor Coagulant ComplexTakeda Pharmaceuticals U.S.A., Inc.Blood or plasma product101447
Sep 7, 1979N/AAlbumin (Human)Central Laboratory of the Netherlands Red Cross Blood Transfusion ServiceBlood or plasma product101993
Aug 15, 1978AlphanateAntihemophilic Factor/von Willebrand Factor Complex (Human)Grifols Biologicals LLCBlood or plasma product102475
Aug 15, 1978AlbuteinAlbumin (Human)Grifols Biologicals LLCBlood or plasma product102478
Nov 21, 1977Pneumovax 23Pneumococcal Vaccine, PolyvalentMerck Sharp & Dohme LLCVaccine101094
Sep 23, 1977Bayhep B, Hyperhep B S/DHepatitis B Immune Globulin (Human)Grifols Therapeutics LLCBlood or plasma product101146
Jul 23, 1976AlburxAlbumin (Human)CSL Behring AGBlood or plasma product102366
Jun 12, 1974Bayrab, HyperrabRabies Immune Globulin (Human)Grifols Therapeutics LLCBlood or plasma product101144
Mar 13, 1974N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifoliaAllermed Laboratories, Inc.Allergenic103113
Mar 12, 1974N/AInsects (Whole Body), Mite Dermatophagoides farinaeAllermed Laboratories, Inc.Allergenic102212
Mar 12, 1974N/AInsects (Whole Body), Mite Dermatophagoides pteronyssinusAllermed Laboratories, Inc.Allergenic102213
Mar 12, 1974N/APollens - Grasses, Fescue, Meadow Festuca elatiorAllermed Laboratories, Inc.Allergenic102216
Mar 12, 1974N/APollens - Grasses, Orchard Grass Dactylis glomerataAllermed Laboratories, Inc.Allergenic102217
Mar 12, 1974N/APollens - Grasses, Redtop Agrostis albaAllermed Laboratories, Inc.Allergenic102218
Mar 12, 1974N/APollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratumAllermed Laboratories, Inc.Allergenic102220
Mar 12, 1974N/AAnimal Allergens, Standardized Cat HairAllermed Laboratories, Inc.Allergenic103473
Jan 24, 1974Koate, Koate-DviAntihemophilic Factor (Human)Grifols Therapeutics LLCBlood or plasma product101130
Dec 16, 1971N/AAnimal Allergens, Standardized Cat HairALK-Abello, Inc.Allergenic103810
Jun 11, 1971Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-DoseRho(D) Immune Globulin (Human)Grifols Therapeutics LLCBlood or plasma product101141
Apr 22, 1971M-M-R IiMeasles, Mumps and Rubella Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine101069
Aug 21, 1970Proplex-T; BebulinFactor IX ComplexBaxalta US Inc.Blood or plasma product103112
Jul 27, 1970TdvaxTetanus and Diphtheria Toxoids AdsorbedMassBiologicsVaccine101322
Jun 9, 1969MERUVAX IIRubella Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine101075
Dec 28, 1967MumpsVaxMumps Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine101072
Aug 28, 1967Antivenin (Micrurus fulvius)Wyeth Pharmaceuticals LLCAntitoxin or antivenom101099
Mar 21, 1963ATTENUVAXMeasles Virus Vaccine LiveMerck Sharp & Dohme LLCVaccine101068
Jan 2, 1959N/ANormal Horse SerumMerck Sharp & Dohme LLCBlood or plasma product101084
Oct 2, 1958PlasmanatePlasma Protein Fraction (Human)Grifols Therapeutics LLCBlood or plasma product101140
Sep 29, 1958N/APollens - Grasses, Bermuda Grass Cynodon dactylonALK-Abello, Inc.Allergenic103051
Sep 15, 1958N/AInsects (Whole Body), Mite Dermatophagoides farinaeGreer Laboratories, Inc.Allergenic101834
Sep 15, 1958N/AInsects (Whole Body), Mite Dermatophagoides pteronyssinusGreer Laboratories, Inc.Allergenic101835
Sep 15, 1958N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatiorGreer Laboratories, Inc.Allergenic101845
Sep 15, 1958N/AAnimal Allergens, Standardized Cat HairGreer Laboratories, Inc.Allergenic103397
Oct 17, 1957Baytet, HypertetTetanus Immune Globulin (Human)Grifols Therapeutics LLCBlood or plasma product101142
Mar 3, 1954Buminate, FlexbuminAlbumin (Human)Takeda Pharmaceuticals U.S.A., Inc.Blood or plasma product101452
Feb 8, 1954N/AAntivenin (Crotalidae) PolyvalentWyeth Pharmaceuticals LLCAntitoxin or antivenom101098
Sep 29, 1950N/APollens - Grasses, Bluegrass, Kentucky (June) Poa pratensisALK-Abello, Inc.Allergenic103052
Sep 29, 1950N/APollens - Grasses, Fescue, Meadow Festuca elatiorALK-Abello, Inc.Allergenic103053
Sep 29, 1950N/APollens - Grasses, Orchard Grass Dactylis glomerataALK-Abello, Inc.Allergenic103054
Sep 29, 1950N/APollens - Grasses, Redtop Agrostis albaALK-Abello, Inc.Allergenic103055
Sep 29, 1950N/APollens - Grasses, Ryegrass, Perennial Lolium perenneALK-Abello, Inc.Allergenic103056
Sep 29, 1950N/APollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratumALK-Abello, Inc.Allergenic103057
Sep 29, 1950N/APollens - Grasses, Timothy Phleum pratenseALK-Abello, Inc.Allergenic103058
Sep 29, 1950N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifoliaALK-Abello, Inc.Allergenic103059
Sep 29, 1950N/AInsects (Whole Body), Mite Dermatophagoides farinaeALK-Abello, Inc.Allergenic103060
Sep 29, 1950N/AAnimal Allergens, Standardized Cat PeltALK-Abello, Inc.Allergenic103061
Sep 29, 1950N/AInsects (Whole Body), Mite Dermatophagoides pteronyssinusALK-Abello, Inc.Allergenic103752
Sep 29, 1950HistatrolPositive Skin Test Control-HistamineALK-Abello, Inc.Skin test103754
Jan 11, 1944Baygam, Gamastan S/DImmune Globulin (Human)Grifols Therapeutics LLCBlood or plasma product101134
Oct 21, 1942Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5Albumin (Human)Grifols Therapeutics LLCBlood or plasma product101138
Feb 13, 1936Antivenin (Latrodectus mactans)Merck Sharp & Dohme LLCAntitoxin or antivenom101062
Jul 11, 1930N/AInsects (Whole Body), Mite Dermatophagoides farinaeAllergy Laboratories, Inc.Allergenic101377
Jul 11, 1930N/AInsects (Whole Body), Mite Dermatophagoides pteronyssinusAllergy Laboratories, Inc.Allergenic101378
Jul 11, 1930N/AAnimal Allergens, Standardized Cat HairAllergy Laboratories, Inc.Allergenic103324
Jun 14, 1930N/APollens - Grasses, Bermuda Grass Cynodon dactylonAllergy Laboratories, Inc.Allergenic101379
Jun 14, 1930N/APollens - Grasses, Bluegrass, Kentucky (June) Poa pratensisAllergy Laboratories, Inc.Allergenic101380
Jun 14, 1930N/APollens - Grasses, Fescue, Meadow Festuca elatiorAllergy Laboratories, Inc.Allergenic101381
Jun 14, 1930N/APollens - Grasses, Orchard Grass Dactylis glomerataAllergy Laboratories, Inc.Allergenic101382
Jun 14, 1930N/APollens - Grasses, Redtop Agrostis albaAllergy Laboratories, Inc.Allergenic101383
Jun 14, 1930N/APollens - Grasses, Ryegrass, Perennial Lolium perenneAllergy Laboratories, Inc.Allergenic101384
Jun 14, 1930N/APollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratumAllergy Laboratories, Inc.Allergenic101385
Jun 14, 1930N/APollens - Grasses, Timothy Phleum pratenseAllergy Laboratories, Inc.Allergenic101386
Jun 14, 1930N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifoliaAllergy Laboratories, Inc.Allergenic101387
Jun 14, 1930N/APollens - Grasses, Bermuda Grass Cynodon dactylonGreer Laboratories, Inc.Allergenic101836
Jun 14, 1930N/APollens - Grasses, Bluegrass, Kentucky (June) Poa pratensisGreer Laboratories, Inc.Allergenic101837
Jun 14, 1930N/APollens - Grasses, Fescue, Meadow Festuca elatiorGreer Laboratories, Inc.Allergenic101838
Jun 14, 1930N/APollens - Grasses, Orchard Grass Dactylis glomerataGreer Laboratories, Inc.Allergenic101839
Jun 14, 1930N/APollens - Grasses, Redtop Agrostis albaGreer Laboratories, Inc.Allergenic101840
Jun 14, 1930N/APollens - Grasses, Ryegrass, Perennial Lolium perenneGreer Laboratories, Inc.Allergenic101841
Jun 14, 1930N/APollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratumGreer Laboratories, Inc.Allergenic101842
Jun 14, 1930N/APollens - Grasses, Timothy Phleum pratenseGreer Laboratories, Inc.Allergenic101843
Jun 14, 1930N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifoliaGreer Laboratories, Inc.Allergenic101844
Jun 14, 1930N/APollens - Grasses, Bermuda Grass Cynodon dactylonAllermed Laboratories, Inc.Allergenic102214
Jun 14, 1930N/APollens - Grasses, Bluegrass, Kentucky (June) Poa pratensisAllermed Laboratories, Inc.Allergenic102215
Jun 14, 1930N/APollens - Grasses, Ryegrass, Perennial Lolium perenneAllermed Laboratories, Inc.Allergenic102219
Jun 14, 1930N/APollens - Grasses, Timothy Phleum pratenseAllermed Laboratories, Inc.Allergenic102221
Mar 13, 1924N/AInsects (Whole Body), Mite Dermatophagoides farinaeJubilant HollisterStier LLCAllergenic103870
Mar 13, 1924N/AInsects (Whole Body), Mite Dermatophagoides pteronyssinusJubilant HollisterStier LLCAllergenic103871
Mar 13, 1924N/APollens - Grasses, Bermuda Grass Cynodon dactylonJubilant HollisterStier LLCAllergenic103872
Mar 13, 1924N/APollens - Grasses, Bluegrass, Kentucky (June) Poa pratensisJubilant HollisterStier LLCAllergenic103873
Mar 13, 1924N/APollens - Grasses, Fescue, Meadow Festuca elatiorJubilant HollisterStier LLCAllergenic103874
Mar 13, 1924N/APollens - Grasses, Orchard Grass Dactylis glomerataJubilant HollisterStier LLCAllergenic103875
Mar 13, 1924N/APollens - Grasses, Redtop Agrostis albaJubilant HollisterStier LLCAllergenic103876
Mar 13, 1924N/APollens - Grasses, Ryegrass, Perennial Lolium perenneJubilant HollisterStier LLCAllergenic103877
Mar 13, 1924N/APollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratumJubilant HollisterStier LLCAllergenic103878
Mar 13, 1924N/APollens - Grasses, Timothy Phleum pratenseJubilant HollisterStier LLCAllergenic103879
Mar 13, 1924N/APollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifoliaJubilant HollisterStier LLCAllergenic103880
Mar 13, 1924N/AVenoms, Honey Bee VenomJubilant HollisterStier LLCAllergenic103882
Mar 13, 1924N/AVenoms, Mixed Vespid Venom ProteinJubilant HollisterStier LLCAllergenic103883
Mar 13, 1924N/AVenoms, Wasp Venom ProteinJubilant HollisterStier LLCAllergenic103884
Mar 13, 1924N/AVenoms, White Faced Hornet Venom ProteinJubilant HollisterStier LLCAllergenic103885
Mar 13, 1924N/AVenoms, Yellow Hornet Venom ProteinJubilant HollisterStier LLCAllergenic103886
Mar 13, 1924N/AVenoms, Yellow Jacket Venom ProteinJubilant HollisterStier LLCAllergenic103887
Mar 13, 1924N/AAnimal Allergens, Standardized Cat HairJubilant HollisterStier LLCAllergenic103889
Mar 13, 1924N/AAnimal Allergens, Standardized Cat PeltJubilant HollisterStier LLCAllergenic103890
Mar 13, 1924N/APositive Skin Test Control-HistamineJubilant HollisterStier LLCSkin test103891

One row per biologics licence application (BLA) the Purple Book lists under CBER, dated by its earliest listed product approval; older licences may show a later date when FDA lists only their current products. Biologics licensed by FDA's drug center (CDER), such as most antibodies, are in our drug pages instead. Refreshed weekly. FDA Purple Book monthly data file

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