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
FluMist® Quadrivalent Influenza Vaccine Live, Intranasal	2/29/2012	Package Insert (PDF - 625KB) Clinical Review (PDF - 576KB) Statistical Review and Evaluation (PDF - 106KB)
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
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	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)
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)
Menveo Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	1/28/2011	Package Insert (PDF - 205 KB) Clinical Review (PDF - 682KB) Statistical Review (PDF - 620KB)
	2/19/2010	Package Insert (PDF - 205 KB) Clinical Review (PDF - 759 KB) 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 (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)	2/24/2010	Package Insert (PDF - 473 KB) Clinical Review (PDF - 12346 KB) Statistical Review and Evaluation (PDF - 1114 KB)
TISSEEL Fibrin Sealant	1/25/2012	Package Insert (PDF - 113KB) Clinical Review (PDF - 415KB) Statistical Review and Evaluation (PDF - 78.8KB)
Rotarix Rotavirus Vaccine, Live, Oral	4/3/2008	Package Insert (PDF - 409 KB) Clinical Review (PDF - 3.6 MB) Statistical Review and Evaluation
Voluven 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection	12/27/2008	Package Insert (PDF - 233 KB) Clinical PREA Review Memo Clinical Pharmacology