Biologics PREA Reviews and Labeling Changes

ACAM2000
Smallpox and Mpox (Vaccinia) Vaccine, Live 8/29/2024 Package Insert ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 1/9/2023 Package Insert
Clinical Review
Statistical Review Advate
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method 12/14/2011 Package Insert
Clinical Review
Statistical Review and Evaluation ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated 12/22/2016 Package Insert
Statistical Review
Clinical Review 11/13/2015 Package Insert
Statistical Review
Clinical Review Afluria
Influenza Virus Vaccine 10/4/2018 Package Insert 11/10/2009 Package Insert
Statistical Review and Evaluation
Clinical Review AFLURIA QUADRIVALENT
Influenza Vaccine 10/4/2018 Package Insert
Clinical Review
Statistical Review
Statistical Review Addendum 8/31/2017 Package Insert
Clinical Review
Statistical Review AFSTYLA
Antihemophilic Factor (Recombinant), Single Chain 5/25/2016 Package Insert
Statistical Review
Clinical Review Agriflu
Influenza Virus Vaccine 1/28/2020 Package Insert
Clinical Review
Statistical Review Artiss
Fibrin Sealant (Human) 3/19/2008 Package Insert
Statistical Review and Evaluation
Clinical Review ASCENIV
Immune Globulin Intravenous, Human-slra, 10% Liquid 4/1/2019 Package Insert
Statistical Review
Clinical Review AUDENZ
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted 1/31/2020 Package Insert
Clinical Review
Statistical Review BEXSERO
Meningococcal Group B Vaccine 1/23/2015 Package Insert
Statistical Review
Clinical Review BIVIGAM
Immune Globulin Intravenous (Human), 10% 12/8/2023 Package Insert
Clinical Review
Statistical Review BOOSTRIX
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 10/7/2022 Package Insert
Clinical Review
Statistical Review Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant 7/14/2011 Statistical Review and Evaluation
Clinical Review 10/16/2009 Package Insert
Statistical Review and Evaluation
Clinical Review Memo COMIRNATY
COVID-19 Vaccine, mRNA 9/11/2023 Package Insert
Clinical Review
Statistical Review 7/8/2022 Package Insert
Clinical Review
Statistical Review 8/23/2021 Package Insert
Clinical Review
Statistical Review
Statistical Review
Statistical Review CUTAQUIG
Immune Globulin Subcutaneous (Human) -hipp, 16.5% 10/22/2021 Package Insert
Clinical Review
Statistical Review CUVITRU
Immune Globulin Subcutaneous (Human), 20% Solution 9/13/2016 Package Insert
Clinical Review
Statistical Review Daptacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed 3/12/2008 Package Insert
Clinical Review DENGVAXIA
DENGUE Tetravalent Vaccine, Live 6/30/2023 Package Insert
Clinical Review
Statistical Review 5/1/2019 Package Insert
Clinical Review
Statistical Review ERVEBO
Ebola Zaire Vaccine, Live 7/27/2023 Package Insert
Clinical Review
Statistical Review ESPEROCT
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei 2/19/2019 Package Insert
Clinical Review
Statistical Review Evicel
Fibrin Sealant (Human) 1/2/2008 Package Insert
Clinical Efficacy Supplement Final Review Memo
Statistical Review and Evaluation FIBRYGA
Fibrinogen (Human) 7/31/2024 Package Insert
Clinical Review
Statistical Review 12/23/2020 Package Insert
Clinical Review
Statistical Review
Clinical Pharmacology Supplemental Review 6/7/2017 Package Insert
Clinical Review
Statistical Review FLUAD
Influenza Vaccine, Adjuvanted 10/28/2020 Package Insert
Clinical Review
Statistical Review FLUAD QUADRIVALENT
Influenza Vaccine, Adjuvanted 12/4/2020 Package Insert 10/28/2020 Clinical Review
Statistical Review Fluarix
Influenza Virus Vaccine 10/19/2009 Package Insert
Statistical Review and Evaluation
Clinical Review Fluarix Quadrivalent
Influenza Virus Vaccine 1/11/2018 Package Insert
Clinical Review
Statistical Review 12/14/2012 Package Insert
Clinical Review
Statistical Review and Evaluation Flucelvax
Influenza Vaccine 5/23/2016 Package Insert
Statistical Review
Clinical Review Addendum Flucelvax Quadrivalent
Influenza Vaccine 10/14/2021 Package Insert
Clinical Review
Statistical Review 3/3/2021 Package Insert
Clinical Review
Statistical Review 5/23/2016 Package Insert
Clinical Review
Statistical Review Addendum
Statistical Review FluLaval
Influenza Virus Vaccine 11/18/2016 Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay 8/16/2013 Package Insert
Clinical Review
Statistical Review and Evaluation FluLaval Quadrivalent
Influenza Virus Vaccine 11/18/2016 Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay 8/15/2013 Package Insert
Statistical Review and Evaluation
Final Clinical Review FluMist Quadrivalent
Influenza Vaccine Live, Intranasal  2/29/2012 Package Insert
Clinical Review
Statistical Review and Evaluation Fluzone High-Dose Quadrivalent
Influenza Virus Vaccine 1/23/2019 Package Insert
Clinical Review
Statistical Review 6/7/2013 Package Insert
Clinical Review
Statistical Review and Evaluation Gammagard Liquid
Immune Globulin Infusion (Human) 7/22/2011 Package Insert
Clinical Review
Statistical Review and Evaluation Gammaplex
Immune Globulin Intravenous (Human) 5% Liquid 7/30/2015 Package Insert
Clinical Review
Statistical Review Gamunex-C
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
  12/4/2015 Package Insert
Clinical Review
Clinical Pharmacology Review Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant 12/22/2010 Package Insert
Clinical Review
Statistical Review and Evaluation 10/16/2009 Package Insert
Clinical Review
Statistical Review 9/12/2008 Package Insert 
Clinical Review
Statistical Review and Evaluation Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant 6/12/2020 Package Insert
Clinical Review 10/7/2016 Package Insert
Clinical Review
Statistical Review 12/10/2014 Package Insert
Clinical Review
Statistical Review Grastek
Timothy Grass Pollen Allergen Extract 4/11/2014 Package Insert
Clinical Review
Statistical Review Hemacord
Hematopoietic progenitor cells, cord blood 11/10/2011 Package Insert
Clinical and Statistical Joint Review Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 1/14/2016 Package Insert
Clinical Review
Statistical Review 8/19/2009 Package Insert
Clinical Review
Statistical Review Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid 9/25/2013 Package Insert 10/3/2011 Package Insert
Statistical Review and Evaluation
Clinical Review 2/17/2011 Package Insert
Clinical Review HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase 4/7/2023 Package Insert
Clinical Review
Statistical Review Ixiaro
Japanese Encephalitis Vaccine, Inactivated, Adsorbed 4/13/2018 Package Insert
Clinical Review
Statistical Review 5/17/2013 Package Insert
Clinical Review
Statistical Review and Evaluation IXINITY
Coagulation Factor IX (Recombinant) 3/22/2024 Package Insert
Statistical Review
Clinical Review
Clinical Pharmacology Review 11/17/2022 Package Insert
Clinical Review
Statistical Review 4/29/2015 Package Insert
Clinical Review 1
Clinical Review 2
Clinical Review 3
Statistical Review and Evaluation JIVI
Antihemophilic Factor (Recombinant), PEGylated-aucl 8/29/2018 Package Insert
Clinical Review
Statistical Review Kedbumin
Albumin (Human) 25% 6/3/2011 Package Insert
Clinical Review
Statistical Review and Evaluation KEDRAB
Rabies Immune Globulin (Human) 5/17/2021 Package Insert
Clinical Review
Preclinical Pharm-Tox Review
Statistical Review Kogenate FS
Antihemophilic Factor (Recombinant) 10/10/2008 Package Insert
Clinical Review KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine 6/24/2008 Package Insert
Clinical Review
Statistical Review KOVALTRY
Antihemophilic Factor (Recombinant) 3/16/2016 Package Insert (Vial Adapter)
Package Insert (BIO-SET)
Clinical Review
Statistical Review Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine 4/22/2011 Package Insert
Clinical Review
Statistical Review
Pharmacovigilance Plan Review MenHibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine 6/14/2012 Package Insert
Statistical Review and Evaluation
Clinical Review MenQuadfi
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine 4/23/2020 Package Insert
Clinical Review
Statistical Review Menveo
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine 8/1/2013 Package Insert
Clinical Review
Statistical Review 1/28/2011 Package Insert
Clinical Review
Statistical Review 2/19/2010 Package Insert
Clinical Review
Statistical Review M-M-R II
Measles, Mumps and Rubella Virus Vaccine Live 2/27/2023 Package Insert
Clinical Review
Statistical Review Novoeight
Antihemophilic Factor (Recombinant) 10/15/2013 Package Insert
Clinical Review
Statistical Review and Evaluation NUWIQ
Antihemophilic Factor (Recombinant) 9/4/2015 Package Insert
Clinical Review
Statistical Review Octaplas
Pooled Plasma (Human), Solvent/Detergent Treated 2/25/2021 Package Insert
Clinical Memo 3/29/2019 Package Insert
Clinical Review ODACTRA
House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract 1/20/2023 Package Insert
Clinical Review
Statistical Review ORALAIR
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract 11/9/2018 Package Insert & Medication Guide
Statistical Review
Clinical Review 4/1/2014 Package Insert
Statistical Review
Clinical Review PALFORZIA
Peanut (Arachis hypogaea) Allergen Powder-dnfp 7/26/2024 Package Insert
Clinical Review
Statistical Review 1/31/2020 Package Insert
Clinical Review
Statistical Review PANZYGA
Immune Globulin Intravenous, human-ifas 8/2/2018 Package Insert
Clinical Review
Statistical Review PENBRAYA
Meningococcal Groups A, B, C, W, and Y Vaccine 10/20/2023 Package Insert
Clinical Review
Statistical Review Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine 6/20/2008 Package Insert
Clinical Review
Statistical Review
Recommendations regarding request for partial waiver of pediatric studies Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) 1/25/2013 Package Insert
Clinical Review
Statistical Review and Evaluation 2/24/2010 Package Insert
Clinical Review
Statistical Review and Evaluation PREVNAR 20
Pneumococcal 20-valent Conjugate Vaccine 4/27/2023 Package Insert
Clinical Review
Statistical Review PRIORIX
Measles, Mumps and Rubella Vaccine, Live 6/3/2022 Package Insert
Clinical Review
Statistical Review PROQUAD
Measles, Mumps, Rubella and Varicella Virus Vaccine Live 2/27/2023 Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review Q-Pan
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted 9/9/2016 Package Insert
Clinical Review
Statistical-Clinical Review
Statistical-Clinical Review – Addendum Quadracel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine 3/24/2015 Package Insert
Clinical Serology and Bioassay Review, and Approval Memo
Clinical Statistical Review RAGWITEK
Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia) 4/16/2021 Package Insert
Clinical Review
Statistical Review REBINYN
Coagulation Factor IX (Recombinant), GlycoPEGylated 5/31/2017 Package Insert
Clinical Review
Statistical Review RECOTHROM
Thrombin, topical (Recombinant) 3/15/2013 Package Insert
Clinical Review
Final Clinical Labeling Memo Rixubis
Coagulation Factor IX (Recombinant) 9/12/2014 Package Insert
Clinical Review
Statistical Review Rotarix
Rotavirus Vaccine, Live, Oral 4/3/2008 Package Insert
Clinical Review
Statistical Review and Evaluation RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent 2/23/2017 Package Insert
Clinical Review
Statistical Review Rubber Panel T.R.U.E. TEST
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test 3/3/2017 Package Insert
Clinical Review
Statistical Review SEVENFACT
coagulation factor VIIa (recombinant)-jncw 11/22/2022 Package Insert
Clinical Review 4/1/2020 Package Insert
Clinical Review
Statistical Review SPIKEVAX
COVID-19 Vaccine, mRNA 9/11/2023 Package Insert
Clinical Review
Statistical Review TachoSil
TACHOSIL® Fibrin Sealant Patch 7/15/2015 Package Insert
Clinical Review
Statistical Review TICOVAC
Tick-Borne Encephalitis Vaccine 8/13/2021 Package Insert
Clinical Review
Statistical Review TISSEEL
Fibrin Sealant 1/25/2012 Package Insert
Clinical Review
Statistical Review and Evaluation T.R.U.E. TEST
Thin-Layer Rapid Use Epicutaneous Patch Test 8/25/2017 Package Insert
Clinical Review
Statistical Review TRUMENBA
Meningococcal Group B Vaccine 4/14/2016 Package Insert
Clinical Review
Statistical Review
Addendum to Statistical Review 10/29/2014 Package Insert
Clinical Review
Statistical Review VARIVAX
Varicella Virus Vaccine Live 2/27/2023 Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review VAXCHORA
Cholera Vaccine, Live, Oral 12/23/2020 Package Insert
Clinical Review
Statistical Review VAXELIS
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine 12/21/2018 Package Insert
Clinical Review
Statistical Review VAXNEUVANCE
Pneumococcal 15-valent Conjugate Vaccine 6/17/2022 Package Insert
Clinical Review
Statistical Review Voluven
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection 5/17/2012 Package Insert
Clinical Review (BN070012/145)
Statistical Review and Evaluation (BN070012/145) 12/27/2008 Package Insert
Clinical PREA Review Memo
Clinical Pharmacology Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human) 3/22/2024 Package Insert
Clinical Review 12/1/2023 Package Insert
Clinical Pharmacology Review
Clinical Review
Statistical Review 9/25/2019 Package Insert
Clinical Review
Statistical Review 8/5/2015 Package Insert
Clinical Review
Statstical Review XEMBIFY
Immune Globulin Subcutaneous, Human – klhw, 20% 7/18/2024 Package Insert 7/3/2019 Package Insert
Clinical Review
Statistical Review XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free 8/13/2020 Package Insert
Package Insert
Clinical Review
Statistical Review YIMMUGO
immune globulin intravenous, human-dira 6/13/2024 Package Insert
Clinical Review
Statistical Review

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