About FDA

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 (PDF - 511KB)
Clinical Review(PDF - 23KB)
Statistical Review and Evaluation (PDF - 389KB)
ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated
12/22/2016 Package Insert (PDF - 655KB)
Statistical Review (PDF - 240KB)
Clinical Review (PDF - 1.7 MB)
11/13/2015 Package Insert (PDF - 655KB)
Statistical Review (PDF - 343KB)
Clinical Review (PDF - 1.3MB)
Afluria
Influenza Virus Vaccine
10/4/2018 Package Insert (PDF - 359KB)
11/10/2009 Package Insert (PDF - 282 KB)
Statistical Review (PDF - 45KB)
Clinical Review (PDF - 803KB)
AFLURIA QUADRIVALENT
Influenza Vaccine
10/4/2018 Package Insert (PDF - 352KB)
Clinical Review (PDF - 1.1 MB)
Statistical Review (PDF - 533KB)
Statistical Review Addendum (PDF - 256KB)
8/31/2017 Package Insert (PDF - 279KB)
Clinical Review (PDF - 965KB)
Statistical Review (PDF - 351KB)
AFSTYLA
Antihemophilic Factor (Recombinant), Single Chain
5/25/2016 Package Insert (PDF - 289 KB)
Statistical Review (PDF - 1 MB)
Clinical Review (PDF - 1.3 MB)
Artiss
Fibrin Sealant (Human)
3/19/2008 Package Insert (PDF - 216 KB)
Statistical Review and Evaluation
Clinical Review (PDF - 808 KB)
BEXSERO
Meningococcal Group B Vaccine
1/23/2015 Package Insert(PDF-141KB)
Statistical Review (PDF-322KB)
Clinical Review (PDF - 1MB)
Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
7/14/2011 Statistical Review and Evaluation (PDF - 87KB)
Clinical Review (PDF - 372KB)
10/16/2009 Package Insert (PDF - 235 KB)
Statistical Review and Evaluation
Clinical Review Memo  (PDF - 16.9MB)
CUVITRU
Immune Globulin Subcutaneous (Human), 20% Solution
9/13/2016 Package Insert (PDF - 606 KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - PDF - 1.7MB)
Daptacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
3/12/2008 Package Insert (PDF - 247 KB)
Clinical Review (PDF - 178 KB)
Evicel
Fibrin Sealant (Human)
1/2/2008 Package Insert (PDF - 164 KB)
Clinical Efficacy Supplement Final Review Memo (PDF - 319 KB)
Statistical Review and Evaluation
FIBRYNA
Fibrinogen (Human)
6/7/2017 Package Insert (PDF - 221KB)
Clinical Review (PDF - 863 KB)
Statistical Review (PDF - 234 KB)
Fluarix
Influenza Virus Vaccine
10/19/2009 Package Insert (PDF - 181KB)
Statistical Review and Evaluation
Clinical Review  
Fluarix Quadrivalent
Influenza Virus Vaccine
1/11/2018 Package Insert (PDF - 585 KB)
Clinical Review (PDF - 1.2 MB)
Statistical Review (PDF - 242 KB)
12/14/2012 Package Insert (PDF-259KB)
Clinical Review (PDF - 818KB)
Statistical Review and Evaluation (PDF - 2.4MB)
Flucelvax
Influenza Vaccine
5/23/2016 Package Insert (PDF - 285 KB)
Statistical Review (PDF - 323 KB)
Clinical Review Addendum (PDF - 158 KB)
Flucelvax Quadrivalent
Influenza Vaccine
5/23/2016 Package Insert (PDF - 193 KB)
Clinical Review (PDF - 679 KB)
Statistical Review Addendum (PDF - 31KB)
Statistical Review (PDF - 464KB)

FluLaval
Influenza Virus Vaccine
11/18/2016 Package Insert  (PDF - 245KB)
Clinical Review (PDF - 523KB)
Statistical Review and Evaluation (PDF - 150KB)
Statistical Review Assay (PDF - 71KB)
8/16/2013 Package Insert (PDF - 206KB)
Clinical Review (PDF - 800KB)
Statistical Review and Evaluation (PDF - 163KB)

FluLaval Quadrivalent
Influenza Virus Vaccine
11/18/2016 Package Insert (PDF - 261KB)
Clinical Review (PDF - 523KB)
Statistical Review and Evaluation (PDF - 150KB)
Statistical Review Assay (PDF - 71KB)
8/15/2013 Package Insert (PDF - 298KB)
Statistical Review and Evaluation (PDF-288KB)
Final Clinical Review (PDF - 2.5MB)
FluMist® Quadrivalent
Influenza Vaccine Live, Intranasal 
2/29/2012 Package Insert (PDF - 625KB)
Clinical Review (PDF - 576KB)
Statistical Review and Evaluation (PDF - 106KB)
Fluzone Quadrivalent
Influenza Virus Vaccine
6/7/2013 Package Insert (PDF -356KB)
Clinical Review (PDF - 970KB)
Statistical Review and Evaluation (PDF - 222KB)
Gammagard Liquid
Immune Globulin Intravenous (Human), 10% Solution
7/22/2011 Package Insert (PDF - 577KB)
Clinical Review (PDF - 371KB)
Statistical Review and Evaluation (PDF - 89KB)
Gammaplex
Immune Globulin Intravenous (Human) 5% Liquid
7/30/2015 Package Insert (PDF - 333KB)
Clinical Review (PDF - 3.1MB)
Statistical Review (PDF - 170KB)
Gamunex-C
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
 
12/4/2015 Package Insert (PDF-741KB)
Clinical Review (PDF -581KB)
Clinical Pharmacology Review (PDF-473KB)
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
12/22/2010 Package Insert (PDF - 460KB)
Clinical Review (PDF - 454KB)
Statistical Review and Evaluation (PDF - 464 KB)
10/16/2009 Package Insert (PDF - 470 KB)
Clinical Review (PDF - 611 KB)
Statistical Review (PDF - 202 KB)
9/12/2008 Package Insert (PDF - 464 KB)
Clinical Review (PDF - 2.52 MB)
Statistical Review and Evaluation
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant
10/7/2016 Package Insert (PDF - 325KB)
Clinical Review (PDF - 395KB)
Statistical Review (PDF - 409KB)
12/10/2014 Package Insert (PDF-256KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - 931KB)
Grastek
Timothy Grass Pollen Allergen Extract
4/11/2014 Package Insert (PDF - 173KB)
Clinical Review (PDF - 1.2MB)
Statistical Review (PDF - 2MB)
Hemacord
Hematopoietic progenitor cells, cord blood
11/10/2011 Package Insert (PDF - 312 KB)
Clinical and Statistical Joint Review (PDF - 609KB)
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
1/14/2016 Package Insert (PDF - 212KB)
Clinical Review (PDF - 676KB)
Statistical Review (PDF - 680KB)
8/19/2009 Package Insert (PDF - 166 KB)
Clinical Review (PDF - 934 KB)
Statistical Review (PDF - 875 KB)

Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid

9/25/2013 Package Insert (PDF-534KB)
10/3/2011 Package Insert (PDF-564 KB)
Statistical Review and Evaluation (PDF - 161KB)
Clinical Review (PDF- 124KB)
2/17/2011 Package Insert (PDF - 546 KB)
Clinical Review (PDF-227KB)
Ixiaro
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
4/13/2018 Package Insert (PDF - 349KB)
Clinical Review (PDF - 380KB)
Statistical Review (PDF - 234KB)
5/17/2013 Package Insert (PDF - 286KB)
Clinical Review (PDF - 743KB)
Statistical Review and Evaluation (PDF - 777KB)
IXINITY
Coagulation Factor IX (Recombinant)
4/29/2015 Package Insert (PDF-500KB)
Clinical Review 1 (PDF - 2.6MB)
Clinical Review 2 (PDF - 2.3MB)
Clinical Review 3 (PDF - 3.6MB)
Statistical Review and Evaluation (PDF - 1018KB)
JIVI
Antihemophilic Factor (Recombinant), PEGylated-aucl
8/29/2018 Package Insert (PDF-503 KB)
Clinical Review (PDF - 729 KB)
Statistical Review (PDF - 1.4 MB)
Kedbumin
Albumin (Human) 25%
6/3/2011 Package Insert (PDF - 216KB)
Clinical Review (PDF - 314KB)
Statistical Review and Evaluation (PDF - 85KB)
Kogenate FS
Antihemophilic Factor (Recombinant)
10/10/2008 Package Insert (PDF - 286 KB)
Clinical Review (PDF - 396 KB)
KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
6/24/2008 Package Insert (PDF - 92 KB)
Clinical Review (PDF - 748 KB)
Statistical Review (PDF - 271 KB)
KOVALTRY
Antihemophilic Factor (Recombinant)
3/16/2016 Package Insert (Vial Adapter) (PDF-412KB)
Package Insert (BIO-SET) (PDF-567KB)
Clinical Review (PDF-2.5 MB)
Statistical Review (PDF-7.2 MB)

Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine

4/22/2011 Package Insert (PDF - 296KB)
Clinical Review (PDF - 337KB)
Statistical Review (PDF - 531KB)
Pharmacovigilance Plan Review (PDF - 25KB)
MenHibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
6/14/2012 Package Insert (PDF - 124KB)
Statistical Review and Evaluation
Clinical Review (PDF - 1.4MB)
Menveo
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
8/1/2013 Package Insert (PDF - 205 KB)
Clinical Review (PDF - 682KB)
Statistical Review (PDF - 783KB)
1/28/2011 Package Insert (PDF - 205 KB)
Clinical Review (PDF - 105MB)
Statistical Review (PDF - 620KB)
2/19/2010 Package Insert (PDF - 205 KB)
Clinical Review (PDF - 759 KB)
Statistical Review
Novoeight
Antihemophilic Factor (Recombinant
10/15/2013 Package Insert - Novoeight (PDF - 455KB)
Clinical Review (PDF-715KB) Statistical Review and Evaluation
NUWIQ
Antihemophilic Factor (Recombinant)
9/4/2015 Package Insert (PDF - 354KB)
Clinical Review (PDF - 1.4MB)
Statistical Review (PDF - 1.6MB)
ORALAIR
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
11/9/2018 Package Insert & Medication Guide(PDF - 240KB)
Statistical Review (PDF - 555KB)
Clinical Review Memo (PDF - 395KB)
4/1/2014 Package Insert (PDF - 284KB)
Statistical Review (PDF-4.4MB)
Clinical Review (PDF - 2.7MB)
PANZYGA
Immune Globulin Intravenous, human-ifas
8/2/2018 Package Insert (PDF - 227KB)
Clinical Review (PDF - 983 KB)
Statistical Review (PDF - 913KB)
Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
6/20/2008 Package Insert (PDF - 379 KB)
Clinical Review (PDF - 1.4 MB)
Statistical Review (PDF - 188 KB)

Recommendations regarding request for partial waiver of pediatric studies

Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
1/25/2013 Package Insert (PDF - 747KB)
Clinical Review (PDF - 672KB)
Statistical Review and Evaluation (PDF-638KB)
2/24/2010 Package Insert (PDF - 473 KB)
Clinical Review (PDF - 12346 KB)

Statistical Review and Evaluation (PDF - 1114 KB)
Q-Pan
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
9/9/2016 Package Insert (PDF - 174KB)
Clinical Review (PDF - 845KB)
Statistical-Clinical Review (PDF - 395KB)
Statistical-Clinical Review - Addendum (PDF - 92KB)
Quadracel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
3/24/2015 Package Insert ( PDF - 177 KB)
Clinical Serology and Bioassay Review, and Approval Memo (PDF - 307KB)
Clinical Statistical Review (PDF - 408KB)
REBINYN
Coagulation Factor IX (Recombinant), GlycoPEGylated
5/31/2017 Package Insert (PDF-424 KB)
Clinical Review (PDF - 1.6MB)
Statistical Review (PDF - 1.8MB)
RECOTHROM
Thrombin, topical (Recombinant)
3/15/2013 Package Insert (PDF - 201KB)
Clinical Review (PDF - 206KB)
Final Clinical Labeling Memo (PDF - 52KB)
Rixubis
Coagulation Factor IX (Recombinant)
9/12/2014 Package Insert (PDF - 358KB)
Clinical Review (PDF - 361KB)
Statistical Review (PDF - 368KB)
Rotarix
Rotavirus Vaccine, Live, Oral
4/3/2008 Package Insert (PDF - 409 KB)
Clinical Review (PDF - 3.6 MB)
Statistical Review and Evaluation 
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent
2/23/2017 Package Insert (PDF-172KB)
Clinical Review (PDF-339KB)
Statistical Review (PDF-331KB)
Rubber Panel T.R.U.E. TEST
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test
3/3/2017 Package Insert (PDF-234KB)
Clinical Review (PDF-1.3MB)
Statistical Review (PDF-633 KB)
TachoSil
TACHOSIL® Fibrin Sealant Patch
7/15/2015 Package Insert (PDF - 584KB)
Clinical Review (PDF - 1013KB)
Statistical Review (PDF - 1.6 MB)
TISSEEL
Fibrin Sealant
1/25/2012 Package Insert (PDF - 113KB)
Clinical Review (PDF - 415KB)
Statistical Review and Evaluation (PDF - 78.8KB)
T.R.U.E. TEST
Thin-Layer Rapid Use Epicutaneous Patch Test
8/25/2017 Package Insert (PDF - 424KB)
Clinical Review (PDF - 435KB)
Statistical Review (PDF - 527KB)
TRUMENBA
Meningococcal Group B Vaccine
4/14/2016 Package Insert (PDF-391KB)
Clinical Review (PDF-474KB)
Statistical Review (PDF-479KB)
Addendum to Statistical Review (PDF-57KB)
10/29/2014 Package Insert (PDF-391KB)
Clinical Review (PDF - 856KB)
Statistical Review (PDF - 1 MB)

Voluven
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection
5/17/2012 Package Insert (PDF - 223KB)
Clinical Review (BN070012/145) (PDF - 62KB)
Statistical Review and Evaluation (BN070012/145) (PDF - 120KB)
12/27/2008 Package Insert (PDF - 233 KB)
Clinical PREA Review Memo
Clinical Pharmacology
Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
8/5/2015 Package Insert (PDF - 367KB)
Clinical Review (PDF - 889KB)
Statstical Review (PDF - 1.5MB)

 

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(800) 835-4709
(240) 402-8010
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Division of Communication and Consumer Affairs

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Food and Drug Administration

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Silver Spring, MD 20993-0002

Page Last Updated: 11/19/2018
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