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

Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abacavir - Ziagen GlaxoSmithKline Medical (PDF - 588KB) Clinical pharmacology (PDF - 248KB) None PREA Abatacept - Orencia Bristol-Myer-Squibb Medical (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 - Ofirmev Cadence Pharmaceuticals, Inc. Medical (PDF -2MB)
Medical (PDF -21KB) Clinical pharmacology (PDF - 2MB) None PREA Acyclovir, Hydrocortisone - Xerese Medivir AB Medical (PDF -1MB) Clinical pharmacology (PDF -120 KB) Statistical (PDF -1MB) PREA Adalimumab - Humira Abbot Medical (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 - Epiduo Galderma Laboratories LP Medical (PDF -1MB) Clinical pharmacology (PDF 1MB) Statistical (PDF -2MB) PREA Adapalene Lotion, 0.1% - Differin Lotion, 0.1% Galderma Laboratories LP Medical (PDF -2MB)
Medical (PDF -38KB) Clinical pharmacology (PDF -752KB) Statistical (PDF -417KB) PREA Adefovir - Hepsera Gilead Sciences Inc Medical (PDF -1MB) Clinical pharmacology (PDF -634KB) Statistical (PDF -309KB) Both Albuterol sulfate HFA - Ventolin HFA GlaxoSmithKline Medical (PDF -1MB) Clinical pharmacology (PDF -133KB) Statistical (PDF -310KB) BPCA Alcaftadine - Lastacaft Vistakon Pharmaceuticals Medical (PDF -597KB) Clinical pharmacology (PDF -741KB) Statistical (PDF -1MB) PREA Alfuzosin - Uroxatral Sanofi-aventis U.S., Inc. Medical (PDF -850KB) Clinical pharmacology (PDF -942KB) Statistical (PDF -447KB) BPCA Almotriptan - Axert Johnson and Johnson Medical (PDF -9MB) Clinical pharmacology (PDF -1MB) None BPCA Amoxicillin/APC -111 - Moxatag MiddleBrook Pharmaceuticals Medical (PDF -3MB) Clinical pharmacology (PDF -751KB) Statistical (PDF -1MB) PREA Amoxicillin/Clavulanate potassium - Augmentin XR GlaxoSmithKline Medical (PDF -67KB) Clinical pharmacology (PDF -264KB) None PREA Anastrozole - Arimidex AstraZeneca Medical (PDF -2MB) Clinical pharmacology (PDF -5MB)[*note for vision impaired users] Statistical (PDF -102KB) BPCA Argatroban - Argatroban ENCYSIVE Pharmaceuticals Inc. Medical (PDF -168KB) Clinical pharmacology (PDF -450 KB) None BPCA Aripiprazole - Abilify Otsuka Pharmaceutical Company Medical (PDF -2MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -381KB) Both Aripiprazole - Abilify Otsuka Pharmaceutical Company Medical (PDF -1MB)
Medical Addendum (PDF -64KB) None Statistical (PDF -338KB) PREA Aripiprazole - Abilify Otsuka Pharmaceutical Development & Commercialization, Inc Medical (PDF -1.24MB) None Statistical (PDF -728KB) PREA Aripiprazole - Abilify Otsuka Pharmaceutical Company, Ltd. Medical (PDF - 2MB) Clinical pharmacology (PDF -51KB Statistical (PDF -800KB) BPCA Atazanavir - Reyataz Bristol-Myers Squibb Company Medical (PDF - 4MB) Clinical pharmacology (PDF -913 KB) None PREA Atazanavir - Reyataz Bristol-Myers Squibb Company Medical (PDF - 461 KB) Clinical pharmacology (PDF - 318 KB) S Statistical (PDF - 682 KB)

BOTH

Azelastine hydrochloride - Astepro MEDA Medical (PDF - 633 KB)
Medical (PDF - 3 MB) Clinical pharmacology (PDF -540 KB) Statistical (PDF - 204 KB)
Statistical (PDF - 985 KB) PREA Azelastine hydrochloride and Fluticasone proprionate - Dymista Meda Pharmaceuticals, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -2MB) PREA Azithromycin - Zmax Pfizer Medical (PDF -76KB) Clinical pharmacology (PDF -67KB) None PREA Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical (PDF -4 MB) Clinical pharmacology (PDF -49KB) None PREA Beclomethasone dipropionate - QNASL Nasal Aerosol Teva Branded Pharmaceutical Products R&D, Inc Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) Statistical (PDF - 714 KB) PREA Bendamustine hydrochloride - Treanda Teva Pharmaceuticals Medical (PDF -6MB) Clinical pharmacology (PDF -1MB) None BPCA Benzyl Alcohol - Ulesfia Asphyxiator Sciele Pharma, Inc Medical (PDF -299KB) Clinical pharmacology (PDF -268KB) Statistical (PDF -932KB) PREA Bepotastine besilate - Bepreve Ista Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -693KB) Statistical (PDF -696KB) PREA Besifloxacin hydrochloride - Besivance Bausch & Lomb Medical (PDF -2MB)[*note for vision impaired users] Clinical pharmacology (PDF -684KB) Statistical (PDF -1MB)[*note for vision impaired users] PREA Bicalutamide - Casodex AstraZeneca Pharmaceuticals Medical (PDF -1MB) Clinical pharmacology (PDF -579KB) Statistical (PDF -207KB) BPCA Bivalirudin - Angiomax The Medicines Company Medical (PDF -717KB) Clinical pharmacology (PDF -2MB) None BPCA Brimonidine tartrate - Timolol maleate - Combigan Allergen, 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 - Atacand Astra Zeneca Medical (PDF -1MB) Clinical pharmacology (PDF -991KB) Statistical (PDF -435KB) BPCA Caspofungin acetate - Cancidas Merck Medical (PDF -3MB) Clinical pharmacology (PDF -465KB) Statistical (PDF -352KB) Both Ciclesonide - Alvesco Aventis Medical (PDF -9MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -300KB) PREA Ciclesonide - Omnaris NYCOMED Medical (PDF -2MB) Clinical pharmacology (PDF -165KB) Statistical (PDF -158KB) PREA Ciprofloxacin otic solution - Cetraxal Parexel International Medical (PDF -282KB) Clinical pharmacology (PDF -245KB) Statistical (PDF -511KB) PREA Clindamycin phosphate/Benzoyl peroxide -Acanya Gel Dow Pharmaceutical Sciences, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -487KB) Statistical (PDF -836KB) PREA Clonidine hydrochloride - Kapvay Shinoga Medical (PDF 1MB) Clinical pharmacology (PDF -225KB) Statistical (PDF -532MB) PREA Clopidogrel bisulfate - Plavix Sanofi Aventis U.S. LLC Medical (PDF -478MB)

Clinical pharmacology (PDF -568KB)

Biopharmaeutic review (PDF -551KB)

Statistical (PDF -72KB) BPCA Colchicine - Colcrys United Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc. Medical (PDF -51KB) Clinical pharmacology (PDF -51KB) None BPCA Colesevelam hydrochloride - Welcho Daiichi-Sankyo Medical (PDF -8MB ) None Statistical (PDF -4MB) Both Darunavir - Prezista Tibotec Medical (PDF -2MB) Clinical pharmacology (PDF - 949KB) None Both Darunavir - Prezista Tibotec, Inc

Medical (PDF -1.8MB)

Medical (PDF -478KB)

Medical (PDF -286KB)

Clinical pharmacology (PDF -2.7MB)

Clinical pharmacology (PDF -793KB)

None BPCA Desmopressin acetate Ferring Pharmaceuticals Inc. Medical (PDF -287KB) Clinical pharmacology (PDF -850KB ) None PREA Dexmethylphenidate hydrochloride - Focalin XR Novartis Pharmaceuticals Corporation Medical (PDF -333KB) Clinical pharmacology (PDF -830KB) Statistical (PDF -151KB) PREA Didanosine - Videx EC Bristol-Myers Squibb Company Medical (PDF -483KB) Clinical pharmacology (PDF -830KB) None PREA Divalproex - Depakote ER and Depakote Sprinkle Abbott

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

Medical (PDF -352KB)

Clinical pharmacology (PDF -100KB)

None Both Docetaxel - Taxotere Sanofi-Aventis Medical (PDF -1MB) Clinical pharmacology (PDF -671KB) Statistical (PDF -427KB) BPCA Drospirenone/Ethinyl estradiol/Levomefolate calcium and Levomefolate calcium - Beyaz Bayer HealthCare Pharmaceuticals Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -399KB)
Statistical Addendum (PDF -22KB) PREA Drospirenone, Ethinyl estradiol, and Levomefolate calcium - Safyral Bayer HealthCare Pharmaceuticals Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -186KB) PREA Eplerenone - Inspra GD Searle LLC Medical (PDF -1MB) Clinical pharmacology (PDF -798KB) Statistical (PDF -338KB) Both Escitalopram - Lexapro Forest Laboratories, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -655KB) Statistical (PDF -772KB) PREA Esomeprazole magnesium - Nexium AstraZeneca Medical (PDF -1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -491KB) PREA Esomeprazole magnesium - Nexium AstraZeneca Medical (PDF -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -336KB) Both Esomeprazole sodium - Nexium I.V. AstraZeneca LP Medical (PDF -644KB) Clinical pharmacology (PDF -2MB) None PREA Estradiol valerate and estradiol valerate/dienogest - Natazia Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF -1.9MB) Clinical pharmacology (PDF -494KB) Statistical (PDF -391KB) PREA Etravirine - Intelence Janssen Products, L.P. Medical (PDF -945KB) Clinical pharmacology (PDF -2MB) None PREA Everolimus - Afinitor Novartis Pharmaceuticals Corporation Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) None BPCA Ezetimbe/simvastatin - Vytorin Merck Schering-Plough Singapore Co., LLC Medical (PDF -2MB) Clinical pharmacology (PDF -200KB) Statistical (PDF -179KB) Both Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC Medical (PDF -336KB) Clinical pharmacology (PDF -86KB) Statistical (PDF -375KB) Both Famciclovir - Famvir Novartis Pharmaceutical Corporation Medical (PDF -779KB) Clinical pharmacology (PDF -354KB) None Both Fluocinolone acetonide - Derma-Smoothe/FS Hill Dermaceuticals, Inc Medical (PDF -943KB) Clinical pharmacology (PDF -276KB) Statistical (PDF -507KB) PREA Fluticasone propionate - Flovent HFA Glaxo Group LTD DBA GlaxoSmithkline Medical (PDF -334KB) Clinical pharmacology (PDF -890KB) None PREA Fosamprenavir calcium - Lexiva ViiV Healthcare Company Medical (PDF -2MB) Clinical pharmacology (PDF -5MB) None Both Fulvestrant - Faslodex AstraZeneca Pharmaceuticals LP Medical (PDF -194KB)
Medical (PDF -538KB) Clinical pharmacology (PDF -437KB) Statistical (PDF -774KB) PREA Gadobenate dimeglumine - MultiHance Bracco Diagnostics Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -455KB) Statistical (PDF -545KB) PREA Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc Medical (PDF -989KB) Clinical pharmacology (PDF -1MB) Statistical (PDF -375KB) PREA Gatifloxacin - Zymar Allergan, Inc. Medical (PDF -573KB) Clinical pharmacology (PDF -60KB) Statistical (PDF -376KB) BPCA Gatifloxacin - Zymaxid Allergan, Inc. Medical (PDF -3MB) Clinical pharmacology (PDF -119KB) Statistical (PDF -611KB) PREA Granisetron hydrochloride - Kytril Hoffmann-La Roche Inc. Medical (PDF -409KB) Clinical pharmacology (PDF -17KB) Statistical (PDF -38KB) PREA Guanfacine - Intuniv Shire Development, Inc. Medical (PDF -440KB) Clinical pharmacology (PDF -286KB) Statistical (PDF -493KB) PREA Guanfacine hydrochloride - Intuniv Shire 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 Kit Braintree Laboratories, Inc Medical (PDF -676KB) Clinical pharmacology (PDF -37KB) Statistical (PDF -236KB) PREA Helioblock SX - Anthelios 40 L’Oreal USA Medical (PDF -4MB) Clinical pharmacology (PDF -2MB) None PREA Hydroxyprogesterone caproate - Makena Hologic, Inc Medical (PDF -439KB) Clinical pharmacology (PDF -36KB) Statistical (PDF -598KB) PREA Imiquimod - Zyclara Cream, 3.75% Graceway Pharmaceuticals, LLC Medical (PDF -1.50MB) Clinical pharmacology (PDF -1.31MB) Statistical (PDF -326KB) PREA Insulin Aspart - NovoLog Novo Nordisk, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -85KB) Statistical (PDF -159KB) PREA Insulin glulisine - Apidra Sanofi-Aventis Medical (PDF -745KB) Clinical pharmacology (PDF -714KB) Statistical (PDF -391KB) PREA Ivermectin - Sklice Sanofi-Topaz, Inc Medical (PDF -2MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -909KB) PREA Ixabepilone - Ixempra Bristol-Myers Squibb Company Medical (PDF -643KB) Clinical pharmacology (PDF - 389KB) Statistical (PDF - 447KB) BPCA Lamotrigine - Lamictal XR GlaxoSmithKline Medical (PDF -52KB) Clinical pharmacology (PDF -3MB) Statistical (PDF -226KB) Both Lamotrigine - Lamictal XR GlaxoSmithKline Medical (PDF -6 MB) None Statistical (PDF -472KB) PREA Lamotrigine - Lamictal XR GlaxoSmithKline Medical (PDF -840KB) Clinical pharmacology (PDF -38KB) Statistical (PDF -391KB) PREA Lansoprazole Oral Suspension - Prevacid TAP Pharmaceutical Products Medical (PDF -1,023KB) Clinical pharmacology (PDF -2MB) Statistical (PDF -54KB) Both Levetiracetam - Keppra XR UCB, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -2MB) Both Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical (PDF -97KB) Clinical pharmacology (PDF -668KB) None Both Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -419KB) None Both Levofloxacin - Levaquin Ortho McNeil Janssen Pharmaceuticals Inc Medical (PDF -239KB) Clinical pharmacology (PDF -828KB) Statistical (PDF -39KB) PREA Levonorgestrel-releasing intrauterine system - Mirena Bayer HealthCare Pharmaceuticals Medical (PDF -1MB) Clinical pharmacology (PDF -358KB) Statistical (PDF -71KB) PREA Levonorgestrel - Plan B one step Duramed Medical (PDF -116KB)
Medical (PDF -315KB) Clinical pharmacology (PDF -47KB)
Clinical pharmacology (PDF -72KB) Statistical (PDF -26KB) PREA Lidocaine hydrochloride - Akten Akorn, Inc. Medical (PDF -120KB) Clinical pharmacology (PDF -57KB) Statistical (PDF -292KB) PREA Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical (PDF -2MB) None (PDF) Statistical (PDF -676KB) PREA Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical (PDF -688KB) None Statistical (PDF -792KB) PREA Lopinavir/ritonavir - Kaletra Abbott Medical (PDF -3MB) Clinical pharmacology (PDF -904KB) None Both Loteprednol etabonate 0.5% and tobramycin 0.3% - Zylet Bausch & Lomb Medical (PDF -37MB)
Medical (PDF -24KB) None None PREA Loteprednol etabonate and tobramycin ophthalmic suspension - Zylet Bausch & Lomb, Incorporated Medical (PDF -84KB) None None BOTH Mannitol - Aridol Pharmaxis Ltd Medical (PDF - 396KB) Clinical pharmacology (PDF -226KB) Statistical (PDF -2MB) PREA Methylphenidate hydrochloride - Quillivant NextWave Pharmaceuticals, Inc.

Medical (PDF -201KB)

Memo (PDF -320KB)

Clinical pharmacology (PDF -67KB)

Clinical pharmacology (PDF -225KB)

Statistical (PDF -241KB PREA Methylphenidate Transdermal System - Daytrana Shire Pharmaceuticals Medical (PDF -2MB)
Medical (PDF -36KB) Clinical pharmacology (PDF -568KB) Statistical (PDF -162KB) PREA Mometasone furoate - Asmanex Twisthaler Schering Plough Corporation Medical (PDF -4MB) Clinical pharmacology (PDF -595KB) Statistical (PDF -548KB)
Statistical (PDF -250KB) PREA Mometasone furoate - Nasonex Schering-Plough Medical (PDF 155KB) None Statistical (PDF -627KB) PREA Mometasone furoate monohydrate - Nasonex Schering-Plough Medical (PDF 435KB) Clinical pharmacology (PDF -143KB) Statistical (PDF -176KB) PREA Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical (PDF -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -433KB) PREA Montelukast sodium - Singulair Merck Sharp & Dohme Corp. Medical (PDF -2MB) Clinical pharmacology (PDF -74KB) Statistical (PDF -94KB) PREA Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF Alcon Research Ltd. Medical (PDF -615KB) Clinical pharmacology (PDF -235KB) Statistical (PDF -580KB) PREA Nevirapine - Viramune Boehringer Ingelheim Medical (PDF -1MB) Clinical pharmacology (PDF -926KB) None PREA Nitric Oxide - INOmax INO Therapeutics Medical (PDF -1MB) Clinical pharmacology (PDF -45KB) Statistical (PDF -612KB) BPCA Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe Warner 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 - TBD Warner Chilcott, LLC Medical (PDF -505KB) Clinical pharmacology (PDF -21KB) Statistical (PDF -106KB) PREA Olanzapine - Zyprexa Eli Lilly Medical (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) Both Olmesartan Medoxomil - Benicar Daiichi Sankyo Medical (PDF -2MB) Clinical pharmacology (PDF -964KB) Statistical (PDF -527KB) Both Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -3MB) PREA Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical (PDF -3.2MB) Clinical pharmacology (PDF -791KB) Statistical (PDF -315KB) Both Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF -1MB) Clinical pharmacology (PDF -845KB) Statistical (PDF -703KB) PREA Omeprazole magnesium - Prilosec AstraZeneca LLP Medical (PDF -318KB) Clinical pharmacology (PDF -869KB) None PREA Paliperidone - Invega Ortho-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 - Pancreaze Johnson & Johnson Pharmaceutical Research & Development, L.L.C Medical (PDF -2MB) Clinical pharmacology (PDF -546KB) Statistical (PDF -326KB) PREA Pancrelipase - Pertyze Digestive Care, Inc. Medical (PDF -4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -736KB) PREA Pancrelipase - Ultrase Axcan Scandipharm, Inc. Medical (PDF -4MB)
Safety (PDF -230KB)
Safety (PDF -119KB)

Clinical pharmacology (PDF -116KB)

Clinical pharmacology (PDF -1MB)

None PREA Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd. Medical (PDF -2MB) Clinical pharmacology (PDF -502KB) Statistical (PDF -377KB) PREA Pantoprazole sodium - Protonix Wyeth 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 - Neulasta Amgen Medical (PDF -965KB) [*note for vision impaired users] Clinical pharmacology (PDF -945KB) [*note for vision impaired users] None PREA Peginterferon - PegIntron Schering-Plough Research Institute Medical (PDF -937KB) Clinical pharmacology (PDF -825KB) Statistical (PDF -1MB) PREA Pemetrexed disodium - Alimta Eli Lilly and Company Medical (PDF -632KB) Clinical pharmacology (PDF -207KB) Statistical (PDF -364KB) BPCA Phentolamine - OraVerse Novalar Pharmaceuticals, Inc. Medical (PDF -4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -762KB) PREA Pilocarpine hydrochloride - Isopto Carpine Alcon Research, Ltd. Medical (PDF -4MB) Clinical pharmacology (PDF -462KB) Statistical (PDF -1MB) PREA Quetiapine fumarate - Seroquel Astra-Zeneca Medical (PDF -3MB)
Medical Addendum (PDF -700KB) Clinical pharmacology (PDF -2MB) Statistical (PDF -776KB) Both Rabeprazole sodium - Aciphex Eisai Medical Research Inc. Medical (PDF -611KB) Clinical pharmacology (PDF -682KB) None PREA Raltegravir - Isentress Merck Sharp & Dohme Corp Medical (PDF -3MB) Clinical pharmacology (PDF -3MB) None PREA Retapamulin - Altabax GlaxoSmithKline Medical (PDF -359KB) Clinical pharmacology (PDF -408KB) None PREA Ribavirin / Peginterferon alfa-2a - Copegus / Pegasys Hoffmann-La Roche Inc Medical (PDF -1MB) Clinical pharmacology (PDF -69KB) Medical (PDF -1MB) PREA Risedronate sodium - Actonel Procter & Gamble Pharmaceuticals, Inc Medical (PDF -437KB) Clinical pharmacology (PDF -636KB) Statistical (PDF -255KB) Both Rizatriptan - Maxalt-MLT Merck Research Laboratories Medical (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) BPCA Rocuronium bromide - Zemuron Organon USA, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -877KB) None Both Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP Medical (PDF -3MB) Clinical pharmacology (PDF -603KB) Statistical (PDF -482KB) Both Saquinavir mesylate - Invirase Hoffmann-La Roche Inc. Medical (PDF -366 KB) Clinical pharmacology (PDF -706KB) Statistical (PDF -446KB) PREA Somatropin - Accretropin Cangene Corporation Medical (PDF -3MB) Clinical pharmacology (PDF -7MB) Statistical (PDF -2MB) PREA Spinosad - Natroba Suspension, 0.9% ParaPRO Medical (PDF -278KB) Clinical pharmacology (PDF -50KB) Statistical (PDF -46KB) Statistical (PDF -23KB) PREA Sterile Intraocular - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical (PDF -8MB) Clinical pharmacology (PDF -85KB) None PREA Tamsulosin hydrochloride - Flomax Boehringer Ingelheim Medical (PDF -3MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -253KB) BPCA Technetium Tc99m - Cardiolite Bristol Myers Squibb Medical (PDF -561KB) Clinical pharmacology (PDF -571KB) Statistical (PDF -357KB) BPCA Temsirolimus - Torisel Wyeth Pharmaceuticals, a Pfizer Company Medical (PDF -2MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -250KB) BPCA Tenofovir disoproxil fumarate - Viread Gilead Medical (PDF -3MB) Clinical pharmacology (PDF -474KB) Statistical (PDF -1MB) PREA Tenofovir disoproxil fumarate - Viread Gilead Sciences, Incorporated Medical (PDF -647KB) Clinical pharmacology (PDF -1.66MB) Statistical (PDF -774KB) BPCA Terbinafine - Lamisil Novartis 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 - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -589KB) Both Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group Medical (PDF -1.4MB) Clinical pharmacology (PDF 670KB) Statistical (PDF -543KB) PREA Topiramate - Topamax Janssen Pharmaceuticals, Inc. Medical (PDF -7MB) Clinical pharmacology (PDF -1MB) None PREA Topiramate - Topamax Johnson and Johnson Pharmaceutical
Research & Development L.L.C. Medical (PDF -3MB) Clinical pharmacology (PDF -986KB) None BPCA Triamcinolone acetonide - Triesence Alcon, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -802KB) Statistical (PDF -402KB) PREA Triamcinolone acetonide - Nasacort AQ Sanofi Aventis Medical (PDF -882KB) Clinical pharmacology (PDF -810KB) Statistical (PDF -615KB) PREA Ulipristal acetate - Ella Laboratoire HRA Pharma Medical (PDF -1MB) Clinical pharmacology (PDF -2MB)
Clinical pharmacology Addendum (PDF -46KB) Statistical (PDF -3MB) PREA Valacyclovir hydrochloride - Valtrex GlaxoSmithKline Medical (PDF -719KB) Clinical pharmacology (PDF -506KB)
Clinical pharmacology (PDF -646KB) None Both Valganciclovir hydrochloride - Valcyte Hoffmann-La Roche, Inc. Medical (PDF -1MB)
Medical (PDF -358KB) Clinical pharmacology (PDF -179KB)
Clinical pharmacology (PDF -2MB) None Both Valsartan - Diovan Novartis Medical (PDF -1MB) Clinical pharmacology (PDF -10MB) Statistical (PDF -2MB) BPCA Varenicline - Chantix Pfizer, Inc. None Clinical pharmacology (PDF -93KB) None PREA Zidovudine, ZDV - Retrovir GlaxoSmithKline Medical (PDF -767KB) Clinical pharmacology (PDF -686KB) None PREA Zidovudine - Retrovir ViiV Healthcare Co Medical (PDF -757KB) Clinical pharmacology (PDF -285) None PREA Ziprasidone - Geodon Pfizer Medical (PDF -2MB)
Medical Addendum (PDF -63KB) Clinical pharmacology (PDF -2MB) Statistical (PDF -359KB) PREA Zoledronic acid - Zometa Novartis Pharmaceutical Corp. Medical (PDF -2MB) Clinical pharmacology (PDF -615KB) Statistical (PDF -422KB) BPCA Zolmitriptan - Zomig AstraZeneca Medical (PDF -2MB) Clinical pharmacology (PDF -703KB) Statistical (PDF -368KB) PREA

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