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
Artiss Fibrin Sealant (Human)	3/19/2008	Package Insert (PDF - 216 KB) Statistical Review and Evaluation Clinical Review (PDF - 808 KB)
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
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant	9/12/2008	Package Insert (PDF, 464 KB) Clinical Review (PDF - 2.52 MB) Statistical Review and Evaluation
	10/16/2009	Package Insert (PDF, 470 KB) Clinical Review (PDF, 611 KB) Statistical Review (PDF, 202 KB)
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)
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)
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
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

Product	Approval Dates	Labeling and Reviews
Artiss Fibrin Sealant (Human)	3/19/2008	Package Insert (PDF - 216 KB) Statistical Review and Evaluation Clinical Review (PDF - 808 KB)
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
Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant	9/12/2008	Package Insert (PDF, 464) Clinical Review (PDF - 2.52 MB) Statistical Review and Evaluation
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)
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)
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
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