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 -1 MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -336KB) Both Esomeprazole sodium – Nexium I.V. AstraZeneca LP Medical (PDF -644 KB) Clinical pharmacology (PDF -2MB) None PREA Estradiol valerate and estradiol valerate/dienogest – Natazia Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF – 2 MB) Clinical pharmacology (PDF -494KB) Statistical (PDF -391KB) PREA Etravirine – Intelence Janssen Products, L.P. Medical (PDF – 945 KB) Clinical pharmacology (PDF -2MB) None PREA Everolimus – Afinitor Novartis Pharmaceuticals Corporation Medical (PDF – 3 MB) Clinical pharmacology (PDF -2MB) None BPCA Ezetimbe/simvastatin – Vytorin Merck Schering-Plough Singapore Co., LLC Medical (PDF – 2 MB) Clinical pharmacology (PDF -200KB) Statistical (PDF -179KB) Both Ezetimbe – Zetia Merck Schering Plough Singapore Co., LLC Medical (PDF – 336 KB) Clinical pharmacology (PDF -86KB) Statistical (PDF -375KB) Both Famciclovir – Famvir Novartis Pharmaceutical Corporation Medical (PDF – 779 KB) Clinical pharmacology (PDF -354KB) None Both Fluocinolone acetonide – Derma-Smoothe/FS Hill Dermaceuticals, Inc Medical (PDF – 943 KB) Clinical pharmacology (PDF -276KB) Statistical (PDF -507KB) PREA Fluticasone furoate – Flonase Sensimist Allergy Relief Haleon US Holdings Medical (PDF – 489 KB) None Statistical (PDF – 133 KB) 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 – 194 KB)
Medical (PDF – 538 KB) Clinical pharmacology (PDF -437KB) Statistical (PDF -774KB) PREA Gadobenate dimeglumine – MultiHance Bracco Diagnostics Inc. Medical (PDF – 1 MB) Clinical pharmacology (PDF -455KB) Statistical (PDF -545KB) PREA Gadobutrol – Gadavist Bayer Healthcare Pharmaceuticals, Inc Medical (PDF – 989 KB) Clinical pharmacology (PDF -1MB) Statistical (PDF -375KB) PREA Gatifloxacin – Zymar Allergan, Inc. Medical (PDF – 573 KB) Clinical pharmacology (PDF -60KB) Statistical (PDF -376KB) BPCA Gatifloxacin – Zymaxid Allergan, Inc. Medical (PDF – 3 MB) Clinical pharmacology (PDF -119KB) Statistical (PDF -611KB) PREA Granisetron hydrochloride – Kytril Hoffmann-La Roche Inc. Medical (PDF – 409 KB) Clinical pharmacology (PDF -17KB) Statistical (PDF -38KB) PREA Guanfacine – Intuniv Shire Development, Inc. Medical (PDF – 440 KB) Clinical pharmacology (PDF -286KB) Statistical (PDF -493KB) PREA Guanfacine hydrochloride – Intuniv Shire Development, Inc. Medical (PDF – 465 KB)
Medical (PDF – 35 KB)
Medical (PDF – 118 KB) 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 – 676 KB) 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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