Reviews of Pediatric Studies Conducted under BPCA and PREA from 2007-2012

In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B(h)(1) of the Act (Pediatric Research Equity Act of 2007 (PREA)), as amended by FDAAA (Pub. L. No. 110-85), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

Total Number of Products Studied under BPCA = 28
Total Number of Products Studied under PREA = 105
Total Number of Products Studied under Both = 31

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Abacavir - ZiagenGlaxoSmithKlineMedical (PDF - 588KB)Clinical pharmacology (PDF - 248KB)NonePREA
Abatacept - OrenciaBristol-Myer-SquibbMedical (PDF -8MB)[*note for vision impaired users]Clinical pharmacology (PDF -4MB)[*note for vision impaired users]Statistical (PDF -24MB)[*note for vision impaired users]PREA
Acetaminophen - OfirmevCadence Pharmaceuticals, Inc.Medical (PDF -2MB)
Medical (PDF -21KB)
Clinical pharmacology (PDF - 2MB)NonePREA
Acyclovir, Hydrocortisone - XereseMedivir ABMedical (PDF -1MB)Clinical pharmacology (PDF -120 KB)Statistical (PDF -1MB)PREA
Adalimumab - HumiraAbbotMedical (PDF -9MB)[*note for vision impaired users]Clinical pharmacology (PDF -1MB)[*note for vision impaired users]Statistical (PDF -3MB)[*note for vision impaired users]PREA
Adapalene - EpiduoGalderma Laboratories LPMedical (PDF -1MB)Clinical pharmacology (PDF 1MB)Statistical (PDF -2MB)PREA
Adapalene Lotion, 0.1% - Differin Lotion, 0.1%Galderma Laboratories LPMedical (PDF -2MB)
Medical (PDF -38KB)
Clinical pharmacology (PDF -752KB)Statistical (PDF -417KB)PREA
Adefovir - HepseraGilead Sciences IncMedical (PDF -1MB)Clinical pharmacology (PDF -634KB)Statistical (PDF -309KB)Both
Albuterol sulfate HFA - Ventolin HFAGlaxoSmithKlineMedical (PDF -1MB)Clinical pharmacology (PDF -133KB)Statistical (PDF -310KB)BPCA
Alcaftadine - LastacaftVistakon PharmaceuticalsMedical (PDF -597KB)Clinical pharmacology (PDF -741KB)Statistical (PDF -1MB)PREA
Alfuzosin - UroxatralSanofi-aventis U.S., Inc.Medical (PDF -850KB)Clinical pharmacology (PDF -942KB)Statistical (PDF -447KB)BPCA
Almotriptan - AxertJohnson and JohnsonMedical (PDF -9MB)Clinical pharmacology (PDF -1MB)NoneBPCA
Amoxicillin/APC -111 - MoxatagMiddleBrook PharmaceuticalsMedical (PDF -3MB)Clinical pharmacology (PDF -751KB)Statistical (PDF -1MB)PREA
Amoxicillin/Clavulanate potassium - Augmentin XRGlaxoSmithKlineMedical (PDF -67KB)Clinical pharmacology (PDF -264KB)NonePREA
Anastrozole - ArimidexAstraZenecaMedical (PDF -2MB)Clinical pharmacology (PDF -5MB)[*note for vision impaired users]Statistical (PDF -102KB)BPCA
Argatroban - ArgatrobanENCYSIVE Pharmaceuticals Inc.Medical (PDF -168KB)Clinical pharmacology (PDF -450 KB)NoneBPCA
Aripiprazole - AbilifyOtsuka Pharmaceutical CompanyMedical (PDF -2MB)Clinical pharmacology (PDF -4MB)Statistical (PDF -381KB)Both
Aripiprazole - AbilifyOtsuka Pharmaceutical CompanyMedical (PDF -1MB)
Medical Addendum (PDF -64KB)
NoneStatistical (PDF -338KB)PREA
Aripiprazole - AbilifyOtsuka Pharmaceutical Development & Commercialization, IncMedical (PDF -1.24MB)NoneStatistical (PDF -728KB)PREA
Aripiprazole - AbilifyOtsuka Pharmaceutical Company, Ltd.Medical (PDF -2MB)Clinical pharmacology (PDF -51KBStatistical (PDF -800KB)BPCA
Atazanavir - ReyatazBristol-Myers Squibb CompanyMedical (PDF -4MB)Clinical pharmacology (PDF -913KB)NonePREA
Azelastine hydrochloride - AsteproMEDAMedical (PDF -633KB)
Medical (PDF -3MB)
Clinical pharmacology (PDF -540KB)Statistical (PDF -204KB)
Statistical (PDF -985KB)
Azelastine hydrochloride and Fluticasone proprionate - DymistaMeda Pharmaceuticals, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -2MB)PREA
Azithromycin - ZmaxPfizerMedical (PDF -76KB)Clinical pharmacology (PDF -67KB)NonePREA
Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating SolutionAlcon, Inc.Medical (PDF -4 MB)Clinical pharmacology (PDF -49KB)NonePREA
Beclomethasone dipropionate - QNASL Nasal AerosolTeva Branded Pharmaceutical Products R&D, IncMedical (PDF -3MB)Clinical pharmacology (PDF -2MB)Statistical (PDF - 714 KB)PREA
Bendamustine hydrochloride - TreandaTeva PharmaceuticalsMedical (PDF -6MB)Clinical pharmacology (PDF -1MB)NoneBPCA
Benzyl Alcohol - Ulesfia AsphyxiatorSciele Pharma, IncMedical (PDF -299KB)Clinical pharmacology (PDF -268KB)Statistical (PDF -932KB)PREA
Bepotastine besilate - BepreveIsta Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -693KB)Statistical (PDF -696KB)PREA
Besifloxacin hydrochloride - BesivanceBausch & LombMedical (PDF -2MB)[*note for vision impaired users]Clinical pharmacology (PDF -684KB)Statistical (PDF -1MB)[*note for vision impaired users]PREA
Bicalutamide - CasodexAstraZeneca PharmaceuticalsMedical (PDF -1MB)Clinical pharmacology (PDF -579KB)Statistical (PDF -207KB)BPCA
Bivalirudin - AngiomaxThe Medicines CompanyMedical (PDF -717KB)Clinical pharmacology (PDF -2MB)NoneBPCA
Brimonidine tartrate - Timolol maleate - CombiganAllergen, Inc.Medical (PDF -2MB)[*note for vision impaired users]Clinical pharmacology (PDF -137KB)[*note for vision impaired users]Statistical (PDF -716KB)[*note for vision impaired users]PREA
Candesartan Cilexitil - AtacandAstra ZenecaMedical (PDF -1MB)Clinical pharmacology (PDF -991KB)Statistical (PDF -435KB)BPCA
Caspofungin acetate - CancidasMerckMedical (PDF -3MB)Clinical pharmacology (PDF -465KB)Statistical (PDF -352KB)Both
Ciclesonide - AlvescoAventisMedical (PDF -9MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -300KB)PREA
Ciclesonide - OmnarisNYCOMEDMedical (PDF -2MB)Clinical pharmacology (PDF -165KB)Statistical (PDF -158KB)PREA
Ciprofloxacin otic solution - CetraxalParexel InternationalMedical (PDF -282KB)Clinical pharmacology (PDF -245KB)Statistical (PDF -511KB)PREA
Clindamycin phosphate/Benzoyl peroxide -Acanya GelDow Pharmaceutical Sciences, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -487KB)Statistical (PDF -836KB)PREA
Clonidine hydrochloride - KapvayShinogaMedical (PDF 1MB)Clinical pharmacology (PDF -225KB)Statistical (PDF -532MB)PREA
Clopidogrel bisulfate - PlavixSanofi Aventis U.S. LLCMedical (PDF -478MB)

Clinical pharmacology (PDF -568KB)

Biopharmaeutic review (PDF -551KB)

Statistical (PDF -72KB)BPCA
Colchicine - ColcrysUnited Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc.Medical (PDF -51KB)Clinical pharmacology (PDF -51KB)NoneBPCA
Colesevelam hydrochloride - WelchoDaiichi-SankyoMedical (PDF -8MB )NoneStatistical (PDF -4MB)Both
Darunavir - PrezistaTibotecMedical (PDF -2MB)Clinical pharmacology (PDF - 949KB)NoneBoth
Darunavir - PrezistaTibotec, Inc

Medical (PDF -1.8MB)

Medical (PDF -478KB)

Medical (PDF -286KB)

Clinical pharmacology (PDF -2.7MB)

Clinical pharmacology (PDF -793KB)

Desmopressin acetateFerring Pharmaceuticals Inc.Medical (PDF -287KB)Clinical pharmacology (PDF -850KB )NonePREA
Dexmethylphenidate hydrochloride - Focalin XRNovartis Pharmaceuticals CorporationMedical (PDF -333KB)Clinical pharmacology (PDF -830KB)Statistical (PDF -151KB)PREA
Didanosine - Videx ECBristol-Myers Squibb CompanyMedical (PDF -483KB)Clinical pharmacology (PDF -830KB)NonePREA
Divalproex - Depakote ER and Depakote SprinkleAbbott

Medical (PDF -100KB)
Medical (PDF -2MB)
Medical (PDF -1MB)

Medical (PDF -352KB)

Clinical pharmacology (PDF -100KB)

Clinical pharmacology (PDF -100KB)

Docetaxel - TaxotereSanofi-AventisMedical (PDF -1MB)Clinical pharmacology (PDF -671KB)Statistical (PDF -427KB)BPCA
Drospirenone/Ethinyl estradiol/Levomefolate calcium and Levomefolate calcium - BeyazBayer HealthCare Pharmaceuticals Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -399KB)
Statistical Addendum (PDF -22KB)
Drospirenone, Ethinyl estradiol, and Levomefolate calcium - SafyralBayer HealthCare Pharmaceuticals Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -186KB)PREA
Eplerenone - InspraGD Searle LLCMedical (PDF -1MB)Clinical pharmacology (PDF -798KB)Statistical (PDF -338KB)Both
Escitalopram - LexaproForest Laboratories, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -655KB)Statistical (PDF -772KB)PREA
Esomeprazole magnesium - NexiumAstraZenecaMedical (PDF -1MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -491KB)PREA
Esomeprazole magnesium - NexiumAstraZenecaMedical (PDF -1MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -336KB)Both
Esomeprazole sodium - Nexium I.V.AstraZeneca LPMedical (PDF -644KB)Clinical pharmacology (PDF -2MB)NonePREA
Estradiol valerate and estradiol valerate/dienogest - NataziaBayer HealthCare Pharmaceuticals, Inc.Medical (PDF -1.9MB)Clinical pharmacology (PDF -494KB)Statistical (PDF -391KB)PREA
Etravirine - IntelenceJanssen Products, L.P.Medical (PDF -945KB)Clinical pharmacology (PDF -2MB)NonePREA
Everolimus - AfinitorNovartis Pharmaceuticals CorporationMedical (PDF -3MB)Clinical pharmacology (PDF -2MB)NoneBPCA
Ezetimbe/simvastatin - VytorinMerck Schering-Plough Singapore Co., LLCMedical (PDF -2MB)Clinical pharmacology (PDF -200KB)Statistical (PDF -179KB)Both
Ezetimbe - ZetiaMerck Schering Plough Singapore Co., LLCMedical (PDF -336KB)Clinical pharmacology (PDF -86KB)Statistical (PDF -375KB)Both
Famciclovir - FamvirNovartis Pharmaceutical CorporationMedical (PDF -779KB)Clinical pharmacology (PDF -354KB)NoneBoth
Fluocinolone acetonide - Derma-Smoothe/FSHill Dermaceuticals, IncMedical (PDF -943KB)Clinical pharmacology (PDF -276KB)Statistical (PDF -507KB)PREA
Fluticasone propionate - Flovent HFAGlaxo Group LTD DBA GlaxoSmithklineMedical (PDF -334KB)Clinical pharmacology (PDF -890KB)NonePREA
Fosamprenavir calcium - LexivaViiV Healthcare CompanyMedical (PDF -2MB)Clinical pharmacology (PDF -5MB)NoneBoth
Fulvestrant - FaslodexAstraZeneca Pharmaceuticals LPMedical (PDF -194KB)
Medical (PDF -538KB)
Clinical pharmacology (PDF -437KB)Statistical (PDF -774KB)PREA
Gadobenate dimeglumine - MultiHanceBracco Diagnostics Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -455KB)Statistical (PDF -545KB)PREA
Gadobutrol - GadavistBayer Healthcare Pharmaceuticals, IncMedical (PDF -989KB)Clinical pharmacology (PDF -1MB)Statistical (PDF -375KB)PREA
Gatifloxacin - ZymarAllergan, Inc.Medical (PDF -573KB)Clinical pharmacology (PDF -60KB)Statistical (PDF -376KB)BPCA
Gatifloxacin - ZymaxidAllergan, Inc.Medical (PDF -3MB)Clinical pharmacology (PDF -119KB)Statistical (PDF -611KB)PREA
Granisetron hydrochloride - KytrilHoffmann-La Roche Inc.Medical (PDF -409KB)Clinical pharmacology (PDF -17KB)Statistical (PDF -38KB)PREA
Guanfacine - IntunivShire Development, Inc.Medical (PDF -440KB)Clinical pharmacology (PDF -286KB)Statistical (PDF -493KB)PREA
Guanfacine hydrochloride - IntunivShire Development, Inc.Medical (PDF -465kb)
Medical (PDF -35KB)
Medical (PDF -118KB)
Clinical pharmacology (PDF -4MB)Statistical (PDF -173KB)PREA
HalfLytely and Bisacodyl Tablets Bowel Prep Kit - PEG 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl - HalfLytely and Bisacodyl Tablet Bowel Prep KitBraintree Laboratories, IncMedical (PDF -676KB)Clinical pharmacology (PDF -37KB)Statistical (PDF -236KB)PREA
Helioblock SX - Anthelios 40L’Oreal USAMedical (PDF -4MB)Clinical pharmacology (PDF -2MB)NonePREA
Hydroxyprogesterone caproate - MakenaHologic, IncMedical (PDF -439KB)Clinical pharmacology (PDF -36KB)Statistical (PDF -598KB)PREA
Imiquimod - Zyclara Cream, 3.75% Graceway Pharmaceuticals, LLCMedical (PDF -1.50MB)Clinical pharmacology (PDF -1.31MB)Statistical (PDF -326KB)PREA
Insulin Aspart - NovoLogNovo Nordisk, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -85KB)Statistical (PDF -159KB)PREA
Insulin glulisine - ApidraSanofi-AventisMedical (PDF -745KB)Clinical pharmacology (PDF -714KB)Statistical (PDF -391KB)PREA
Ivermectin - SkliceSanofi-Topaz, IncMedical (PDF -2MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -909KB)PREA
Ixabepilone - IxempraBristol-Myers Squibb CompanyMedical (PDF -643KB)Clinical pharmacology (PDF - 389KB)Statistical (PDF - 447KB)BPCA
Lamotrigine - Lamictal XRGlaxoSmithKlineMedical (PDF -52KB)Clinical pharmacology (PDF -3MB)Statistical (PDF -226KB)Both
Lamotrigine - Lamictal XRGlaxoSmithKlineMedical (PDF -6 MB)NoneStatistical (PDF -472KB)PREA
Lamotrigine - Lamictal XRGlaxoSmithKlineMedical (PDF -840KB)Clinical pharmacology (PDF -38KB)Statistical (PDF -391KB)PREA
Lansoprazole Oral Suspension - PrevacidTAP Pharmaceutical ProductsMedical (PDF -1,023KB)Clinical pharmacology (PDF -2MB)Statistical (PDF -54KB)Both
Levetiracetam - KeppraUCB, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -2MB)Both
Levocetirizine dihydrochloride - XyzalUCB, Inc.Medical (PDF -97KB)Clinical pharmacology (PDF -668KB)NoneBoth
Levocetirizine dihydrochloride - XyzalUCB, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -419KB)NoneBoth
Levofloxacin - LevaquinOrtho McNeil Janssen Pharmaceuticals IncMedical (PDF -239KB)Clinical pharmacology (PDF -828KB)Statistical (PDF -39KB)PREA
Levonorgestrel-releasing intrauterine system - MirenaBayer HealthCare PharmaceuticalsMedical (PDF -1MB)Clinical pharmacology (PDF -358KB)Statistical (PDF -71KB)PREA
Levonorgestrel - Plan B one stepDuramedMedical (PDF -116KB)
Medical (PDF -315KB)
Clinical pharmacology (PDF -47KB)
Clinical pharmacology (PDF -72KB)
Statistical (PDF -26KB)PREA
Lidocaine hydrochloride - AktenAkorn, Inc.Medical (PDF -120KB)Clinical pharmacology (PDF -57KB)Statistical (PDF -292KB)PREA
Lisdexamfetamine dimesylate - VyvanseShire Development, Inc.Medical (PDF -2MB)None (PDF)Statistical (PDF -676KB)PREA
Lisdexamfetamine dimesylate - VyvanseShire Development, Inc.Medical (PDF -688KB)NoneStatistical (PDF -792KB)PREA
Lopinavir/ritonavir - KaletraAbbottMedical (PDF -3MB)Clinical pharmacology (PDF -904KB)NoneBoth
Loteprednol etabonate 0.5% and tobramycin 0.3% - ZyletBausch & LombMedical (PDF -37MB)
Medical (PDF -24KB)
Loteprednol etabonate and tobramycin ophthalmic suspension - ZyletBausch & Lomb, IncorporatedMedical (PDF -84KB)NoneNoneBOTH
Mannitol - AridolPharmaxis LtdMedical (PDF - 396KB)Clinical pharmacology (PDF -226KB)Statistical (PDF -2MB)PREA
Methylphenidate hydrochloride - QuillivantNextWave Pharmaceuticals, Inc.

Medical (PDF -201KB)

Memo (PDF -320KB)

Clinical pharmacology (PDF -67KB)

Clinical pharmacology (PDF -225KB)

Statistical (PDF -241KBPREA
Methylphenidate Transdermal System - DaytranaShire PharmaceuticalsMedical (PDF -2MB)
Medical (PDF -36KB)
Clinical pharmacology (PDF -568KB)Statistical (PDF -162KB)PREA
Mometasone furoate - Asmanex TwisthalerSchering Plough CorporationMedical (PDF -4MB)Clinical pharmacology (PDF -595KB)Statistical (PDF -548KB)
Statistical (PDF -250KB)
Mometasone furoate - NasonexSchering-PloughMedical (PDF 155KB)NoneStatistical (PDF -627KB)PREA
Mometasone furoate monohydrate - NasonexSchering-PloughMedical (PDF 435KB)Clinical pharmacology (PDF -143KB)Statistical (PDF -176KB)PREA
Mometasone furoate and formoterol fumarate - DuleraSchering-PloughMedical (PDF -1MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -433KB)PREA
Montelukast sodium - SingulairMerck Sharp & Dohme Corp.Medical (PDF -2MB)Clinical pharmacology (PDF -74KB)Statistical (PDF -94KB)PREA
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AFAlcon Research Ltd.Medical (PDF -615KB)Clinical pharmacology (PDF -235KB)Statistical (PDF -580KB)PREA
Nevirapine - ViramuneBoehringer IngelheimMedical (PDF -1MB)Clinical pharmacology (PDF -926KB)NonePREA
Nitric Oxide - INOmaxINO TherapeuticsMedical (PDF -1MB)Clinical pharmacology (PDF -45KB)Statistical (PDF -612KB)BPCA
Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin FeWarner Chilcott Company, Inc.Medical (PDF -166KB)Clinical pharmacology (PDF -50KB)Statistical (PDF -31KB)PREA
Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBDWarner Chilcott, LLCMedical (PDF -505KB)Clinical pharmacology (PDF -21KB)Statistical (PDF -106KB)PREA
Olanzapine - ZyprexaEli LillyMedical (PDF -41KB)
Medical (PDF -40KB)
Medical (PDF -62KB)

Medical (PDF -2MB)
Medical (PDF -604KB)

BPCA Summary (PDF -76KB

Clinical pharmacology (PDF -962KB)Statistical (PDF -452KB)
Statistical Addendum (PDF -159KB)
Olmesartan Medoxomil - BenicarDaiichi SankyoMedical (PDF -2MB)Clinical pharmacology (PDF -964KB)Statistical (PDF -527KB)Both
Olopatadine hydrochloride - PatanaseAlcon Research, Ltd.Medical (PDF -3MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -3MB)PREA
Olopatadine hydrochloride - PatanaseAlcon Research, Ltd.Medical (PDF -3.2MB)Clinical pharmacology (PDF -791KB)Statistical (PDF -315KB)Both
Omalizumab - XolairGenentech, Inc. and Novartis Pharmaceuticals Corp.Medical (PDF -1MB)Clinical pharmacology (PDF -845KB)Statistical (PDF -703KB)PREA
Omeprazole magnesium - PrilosecAstraZeneca LLPMedical (PDF -318KB)Clinical pharmacology (PDF -869KB)NonePREA
Paliperidone - InvegaOrtho-McNeil-Janssen Pharmaceuticals, Inc.Medical (PDF -289MB)Clinical pharmacology (PDF -447KB)Statistical (PDF -252KB)BOTH
Pancrelipase - Creon Abbott Products Inc.Medical (PDF -702KB)Clinical pharmacology (PDF -58KB)Statistical (PDF -84KB)PREA
Pancrelipase - PancreazeJohnson & Johnson Pharmaceutical Research & Development, L.L.CMedical (PDF -2MB)Clinical pharmacology (PDF -546KB)Statistical (PDF -326KB)PREA
Pancrelipase - PertyzeDigestive Care, Inc.Medical (PDF -4MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -736KB)PREA
Pancrelipase - UltraseAxcan Scandipharm, Inc.Medical (PDF -4MB)
Safety (PDF -230KB)
Safety (PDF -119KB)

Clinical pharmacology (PDF -116KB)

Clinical pharmacology (PDF -1MB)

Pancrelipase - ZenpepEurand Pharmaceuticals Ltd.Medical (PDF -2MB)Clinical pharmacology (PDF -502KB)Statistical (PDF -377KB)PREA
Pantoprazole sodium - ProtonixWyeth Pharmaceuticals, Inc.DD Summary Review (PDF -907KB)
CDTL Review (PDF -597KB)
Medical (PDF -11MB)
Medical Addendum (PDF -260KB)
Clinical pharmacology (PDF -8MB)Statistical (PDF -721KB)Both
Pegfilgrastim - NeulastaAmgenMedical (PDF -965KB) [*note for vision impaired users]Clinical pharmacology (PDF -945KB) [*note for vision impaired users]NonePREA
Peginterferon - PegIntronSchering-Plough Research InstituteMedical (PDF -937KB)Clinical pharmacology (PDF -825KB)Statistical (PDF -1MB)PREA
Pemetrexed disodium - AlimtaEli Lilly and CompanyMedical (PDF -632KB)Clinical pharmacology (PDF -207KB)Statistical (PDF -364KB)BPCA
Phentolamine - OraVerseNovalar Pharmaceuticals, Inc.Medical (PDF -4MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -762KB)PREA
Pilocarpine hydrochloride - Isopto CarpineAlcon Research, Ltd.Medical (PDF -4MB)Clinical pharmacology (PDF -462KB)Statistical (PDF -1MB)PREA
Quetiapine fumarate - SeroquelAstra-ZenecaMedical (PDF -3MB)
Medical Addendum (PDF -700KB)
Clinical pharmacology (PDF -2MB)Statistical (PDF -776KB)Both
Rabeprazole sodium - AciphexEisai Medical Research Inc.Medical (PDF -611KB)Clinical pharmacology (PDF -682KB)NonePREA
Raltegravir - IsentressMerck Sharp & Dohme CorpMedical (PDF -3MB)Clinical pharmacology (PDF -3MB)NonePREA
Retapamulin - AltabaxGlaxoSmithKlineMedical (PDF -359KB)Clinical pharmacology (PDF -408KB)NonePREA
Ribavirin / Peginterferon alfa-2a - Copegus / PegasysHoffmann-La Roche IncMedical (PDF -1MB)Clinical pharmacology (PDF -69KB)Medical (PDF -1MB)PREA
Risedronate sodium - ActonelProcter & Gamble Pharmaceuticals, IncMedical (PDF -437KB)Clinical pharmacology (PDF -636KB)Statistical (PDF -255KB)Both
Rizatriptan - Maxalt-MLTMerck Research LaboratoriesMedical (PDF -2.6MB)
Medical (PDF -659KB)
CTDL Review (PDF -221KB)
CTDL Addendum (PDF -112KB)
DD Memo (PDF -22KB)
Clinical pharmacology (PDF -2MB)Statistical (PDF -374KB)
Statistical (PDF -381KB)
Rocuronium bromide - ZemuronOrganon USA, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -877KB)NoneBoth
Rosuvastatin - CrestorAstraZeneca Pharmaceuticals LPMedical (PDF -3MB)Clinical pharmacology (PDF -603KB)Statistical (PDF -482KB)Both
Saquinavir mesylate - InviraseHoffmann-La Roche Inc.Medical (PDF -366 KB)Clinical pharmacology (PDF -706KB)Statistical (PDF -446KB)PREA
Somatropin - AccretropinCangene CorporationMedical (PDF -3MB)Clinical pharmacology (PDF -7MB)Statistical (PDF -2MB)PREA
Spinosad - Natroba Suspension, 0.9%ParaPROMedical (PDF -278KB)Clinical pharmacology (PDF -50KB)Statistical (PDF -46KB)   Statistical (PDF -23KB)   PREA
Sterile Intraocular - Navstel Intraocular Irrigating SolutionAlcon, Inc.Medical (PDF -8MB)Clinical pharmacology (PDF -85KB)NonePREA
Tamsulosin hydrochloride - FlomaxBoehringer IngelheimMedical (PDF -3MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -253KB)BPCA
Technetium Tc99m - CardioliteBristol Myers SquibbMedical (PDF -561KB)Clinical pharmacology (PDF -571KB)Statistical (PDF -357KB)BPCA
Temsirolimus - Torisel Wyeth Pharmaceuticals, a Pfizer CompanyMedical (PDF -2MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -250KB)BPCA
Tenofovir disoproxil fumarate - VireadGileadMedical (PDF -3MB)Clinical pharmacology (PDF -474KB)Statistical (PDF -1MB)PREA
Tenofovir disoproxil fumarate - VireadGilead Sciences, IncorporatedMedical (PDF -647KB)Clinical pharmacology (PDF -1.66MB)Statistical (PDF -774KB)BPCA
Terbinafine - LamisilNovartis Pharmaceuticals Corp.Medical (PDF -6MB)[*note for vision impaired users]Clinical pharmacology (PDF -3MB)[*note for vision impaired users]Statistical (PDF -2MB)[*note for vision impaired users]BPCA
Tipranavir - AptivusBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -589KB)Both
Tocilizumab - ActemraGenentech, Inc. A Member of the Roche GroupMedical (PDF -1.4MB)Clinical pharmacology (PDF 670KB)Statistical (PDF -543KB)PREA
Topiramate - TopamaxJanssen Pharmaceuticals, Inc.Medical (PDF -7MB)Clinical pharmacology (PDF -1MB)NonePREA
Topiramate - TopamaxJohnson and Johnson Pharmaceutical
Research & Development L.L.C.
Medical (PDF -3MB)Clinical pharmacology (PDF -986KB)NoneBPCA
Triamcinolone acetonide - TriesenceAlcon, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -802KB)Statistical (PDF -402KB)PREA
Triamcinolone acetonide - Nasacort AQSanofi AventisMedical (PDF -882KB)Clinical pharmacology (PDF -810KB)Statistical (PDF -615KB)PREA
Ulipristal acetate - EllaLaboratoire HRA PharmaMedical (PDF -1MB)Clinical pharmacology (PDF -2MB)
Clinical pharmacology Addendum (PDF -46KB)
Statistical (PDF -3MB)PREA
Valacyclovir hydrochloride - ValtrexGlaxoSmithKlineMedical (PDF -719KB)Clinical pharmacology (PDF -506KB)
Clinical pharmacology (PDF -646KB)
Valganciclovir hydrochloride - ValcyteHoffmann-La Roche, Inc.Medical (PDF -1MB)
Medical (PDF -358KB)
Clinical pharmacology (PDF -179KB)
Clinical pharmacology (PDF -2MB)
Valsartan - DiovanNovartisMedical (PDF -1MB)Clinical pharmacology (PDF -10MB)Statistical (PDF -2MB)BPCA
Varenicline - ChantixPfizer, Inc.NoneClinical pharmacology (PDF -93KB)NonePREA
Zidovudine, ZDV - RetrovirGlaxoSmithKlineMedical (PDF -767KB)Clinical pharmacology (PDF -686KB)NonePREA
Zidovudine - RetrovirViiV Healthcare CoMedical (PDF -757KB)Clinical pharmacology (PDF -285)NonePREA
Ziprasidone - GeodonPfizerMedical (PDF -2MB)
Medical Addendum (PDF -63KB)
Clinical pharmacology (PDF -2MB)Statistical (PDF -359KB)PREA
Zoledronic acid - ZometaNovartis Pharmaceutical Corp.Medical (PDF -2MB)Clinical pharmacology (PDF -615KB)Statistical (PDF -422KB)BPCA
Zolmitriptan - ZomigAstraZenecaMedical (PDF -2MB)Clinical pharmacology (PDF -703KB)Statistical (PDF -368KB)PREA

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