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  6. Biologics PREA Reviews and Labeling Changes
  1. Center for Biologics Evaluation and Research (CBER)

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
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
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
BEXSERO
Meningococcal Group B Vaccine
1/23/2015 Package Insert
Statistical Review
Clinical 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
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
5/1/2019 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
FIBRYNA
Fibrinogen (Human)
6/7/2017 Package Insert
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
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 Quadrivalent
Influenza Virus Vaccine
6/7/2013 Package Insert
Clinical Review
Statistical Review and Evaluation
Gammagard Liquid
Immune Globulin Intravenous (Human), 10% Solution
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
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
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)
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
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
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
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
3/29/2019 Package Insert
Clinical 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
PANZYGA
Immune Globulin Intravenous, human-ifas
8/2/2018 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
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
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
TachoSil
TACHOSIL® Fibrin Sealant Patch
7/15/2015 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
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

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)
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%
7/3/2019 Package Insert
Clinical Review
Statistical Review

 

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