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)

Afluria
Influenza Virus Vaccine
11/10/2009 Package Insert (PDF - 265 KB)
Statistical Review and Evaluation (PDF - 45KB)
Clinical Review (PDF - 803KB) 
Artiss
Fibrin Sealant (Human)
3/19/2008 Package Insert (PDF - 216 KB)
Statistical Review and Evaluation
Clinical Review (PDF - 808 KB)
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)
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 - 171 KB)
Clinical Efficacy Supplement Final Review Memo (PDF - 319 KB)
Statistical Review and Evaluation
Fluarix
Influenza Virus Vaccine
 
10/19/2009 Package Insert (PDF - 181KB)
Statistical Review and Evaluation
Clinical Review  
Fluarix Quadrivalent
Influenza Virus Vaccine
 
12/14/2012 Package Insert (PDF-259KB)
Clinical Review (PDF - 818KB)
Statistical Review and Evaluation (PDF - 2.4MB)
FluLaval
Influenza Virus Vaccine
 
8/16/2013 Package Insert (PDF - 206KB)
Clinical Review (PDF - 800KB)
Statistical Review and Evaluation (PDF - 163KB)
 
FluLaval Quadrivalent
Influenza Virus Vaccine
 
8/16/2013

Package Insert (PDF - 298KB)

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)
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
Grastek 
Timothy Grass Pollen Allergen Extract
4/11/2014

Package Insert (PDF-173KB)
Clinical Review (PDF-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)
 
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
5/17/2013 Package Insert (PDF - 286KB)
Clinical Review (PDF - 743KB)
Statistical Review and Evaluation (PDF - 777KB)

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)

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

4/22/2011

Package Insert - Menactra (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)
Statistical Review and Evaluation
Clinical Review (PDF-715KB)
 

ORALAIR
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
 
4/1/2014 Package Insert (PDF - 284KB)
Statistical Review (PDF-4.4MB)
Clinical Review (PDF - 2.7MB) 
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)
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 
TISSEEL
Fibrin Sealant
 
1/25/2012 Package Insert (PDF - 113KB)
Clinical Review (PDF - 415KB)
Statistical Review and Evaluation (PDF - 78.8KB)
 
TRUMENBA
Meningococcal Group B Vaccine
10/29/2014 Package Insert (PDF - 273KB)

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

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 10/31/2014
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