Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA).

These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

In accordance with section 505B(h)(1) of the Act as amended, links are provided in the table below to the medical, statistical, and clinical pharmacology reviews of pediatric assessments conducted under PREA. In accordance with section 505B(f)(6)(G) of the Act as amended, links are provided in the table below to currently approved labels (package inserts) that contain changes made as a result of a pediatric assessment.

Product	Approval Dates	Labeling and Reviews
ACAM2000 Smallpox and Mpox (Vaccinia) Vaccine, Live	8/29/2024	Package Insert Clinical Review Statistical Review
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	8/27/2025	Package Insert Clinical Review Statistical Review
	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
Flublok Influenza Vaccine	3/31/2025	Package Insert  Clinical Review  Statistical Review
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)	6/27/2025	Package Insert
	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
IMOVAX RABIES Rabies Vaccine	7/24/2025	Package Insert Clinical Review Statistical Review
ITVISMA Adeno-associated virus (AAV) vector-based gene therapy	11/24/2025	Package Insert
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	5/23/2025	Package Insert  Clinical Review  Statistical Review
	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
MNEXSPIKE COVID-19 Vaccine, mRNA	5/30/2025	Package Insert Clinical Review Statistical Review
Novoeight Antihemophilic Factor (Recombinant)	10/15/2013	Package Insert Clinical Review Statistical Review and Evaluation
NUVAXOVID COVID-19 Vaccine, Adjuvanted	5/16/2025	Package Insert Clinical Review Statistical Review
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	2/27/2025	Package Insert Clinical Review Statistical Review
	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
PENMENVY Meningococcal Groups A, B, C, W, and Y Vaccine	2/14/2025	Package Insert CBER Integrated 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	07/09/2025	Package Insert Clinical Review Statistical Review
	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
VIMKUNYA Chikungunya Vaccine, Recombinant	2/14/2025	Package Insert  Clinical Review  Statistical Review
VONVENDI von Willebrand Factor (recombinant)	9/5/2025	Package Insert Clinical Review Statistical Review
VISTASEAL FIBRIN SEALANT (Human)	9/27/2024	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 Clinical and Clinical Pharmacology Review Statistical Review
	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

 

Related Information

• List of Determinations Made by CBER Including Written Request