sábado, 16 de febrero de 2013

Development Resources > Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

Development Resources > Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

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 = 27
Total Number of Products Studied under PREA = 104
Total Number of Products Studied under Both = 30


Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both
Abacavir - Ziagen GlaxoSmithKline Medical1 (PDF - 588KB) Clinical pharmacology2 (PDF - 248KB) None PREA
Abatacept - Orencia Bristol-Myer-Squibb Medical3 (PDF -8MB)[*note for vision impaired users] Clinical pharmacology4 (PDF -4MB)[*note for vision impaired users] Statistical5 (PDF -24MB)[*note for vision impaired users] PREA
Acetaminophen - Ofirmev Cadence Pharmaceuticals, Inc. Medical6 (PDF -2MB)
Medical7 (PDF -21KB)
Clinical pharmacology8 (PDF - 2MB) None PREA
Acyclovir, Hydrocortisone - Xerese Medivir AB Medical9 (PDF -1MB) Clinical pharmacology10 (PDF -120 KB) Statistical11 (PDF -1MB) PREA
Adalimumab - Humira Abbot Medical12 (PDF -9MB)[*note for vision impaired users] Clinical pharmacology13 (PDF -1MB)[*note for vision impaired users] Statistical14 (PDF -3MB)[*note for vision impaired users] PREA
Adapalene - Epiduo Galderma Laboratories LP Medical15 (PDF -1MB) Clinical pharmacology16 (PDF 1MB) Statistical17 (PDF -2MB) PREA
Adapalene Lotion, 0.1% - Differin Lotion, 0.1% Galderma Laboratories LP Medical18 (PDF -2MB)
Medical19 (PDF -38KB)
Clinical pharmacology20 (PDF -752KB) Statistical21 (PDF -417KB) PREA
Adefovir - Hepsera Gilead Sciences Inc Medical22 (PDF -1MB) Clinical pharmacology23 (PDF -634KB) Statistical24 (PDF -309KB) Both
Albuterol sulfate HFA - Ventolin HFA GlaxoSmithKline Medical25 (PDF -1MB) Clinical pharmacology26 (PDF -133KB) Statistical27 (PDF -310KB) BPCA
Alcaftadine - Lastacaft Vistakon Pharmaceuticals Medical28 (PDF -597KB) Clinical pharmacology29 (PDF -741KB) Statistical30 (PDF -1MB) PREA
Alfuzosin - Uroxatral Sanofi-aventis U.S., Inc. Medical31 (PDF -850KB) Clinical pharmacology32 (PDF -942KB) Statistical33 (PDF -447KB) BPCA
Almotriptan - Axert Johnson and Johnson Medical34 (PDF -9MB) Clinical pharmacology35 (PDF -1MB) None BPCA
Amoxicillin/APC -111 - Moxatag MiddleBrook Pharmaceuticals Medical36 (PDF -3MB) Clinical pharmacology37 (PDF -751KB) Statistical38 (PDF -1MB) PREA
Amoxicillin/Clavulanate potassium - Augmentin XR GlaxoSmithKline Medical39 (PDF -67KB) Clinical pharmacology40 (PDF -264KB) None PREA
Anastrozole - Arimidex AstraZeneca Medical41 (PDF -2MB) Clinical pharmacology42 (PDF -5MB)[*note for vision impaired users] Statistical43 (PDF -102KB) BPCA
Argatroban - Argatroban ENCYSIVE Pharmaceuticals Inc. Medical44 (PDF -168KB) Clinical pharmacology45 (PDF -450 KB) None BPCA
Aripiprazole - Abilify Otsuka Pharmaceutical Company Medical46 (PDF -2MB) Clinical pharmacology47 (PDF -4MB) Statistical48 (PDF -381KB) Both
Aripiprazole - Abilify Otsuka Pharmaceutical Company Medical49 (PDF -1MB)
Medical Addendum50 (PDF -64KB)
None Statistical51 (PDF -338KB) PREA
Aripiprazole - Abilify Otsuka Pharmaceutical Development & Commercialization, Inc Medical 52(PDF -1.24MB) None Statistical 53(PDF -728KB) PREA
Atazanavir - Reyataz Bristol-Myers Squibb Company Medical54 (PDF -4MB) Clinical pharmacology55 (PDF -913KB) None PREA
Azelastine hydrochloride - Astepro MEDA Medical56 (PDF -633KB)
Medical57 (PDF -3MB)
Clinical pharmacology58 (PDF -540KB) Statistical59 (PDF -204KB)
Statistical60 (PDF -985KB)
Azelastine hydrochloride and Fluticasone proprionate - Dymista Meda Pharmaceuticals, Inc. Medical61 (PDF -1MB) Clinical pharmacology62 (PDF -2MB) Statistical63 (PDF -2MB) PREA
Azithromycin - Zmax Pfizer Medical64 (PDF -76KB) Clinical pharmacology65 (PDF -67KB) None PREA
Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical66 (PDF -4 MB) Clinical pharmacology67 (PDF -49KB) None PREA
Beclomethasone dipropionate - QNASL Nasal Aerosol Teva Branded Pharmaceutical Products R&D, Inc Medical 68(PDF -3MB) Clinical pharmacology69 (PDF -2MB) Statistical 70(PDF -6KB) PREA
Bendamustine hydrochloride - Treanda Teva Pharmaceuticals Medical71 (PDF -6MB) Clinical pharmacology72 (PDF -1MB) None PREA
Benzyl Alcohol - Ulesfia Asphyxiator Sciele Pharma, Inc Medical73 (PDF -299KB) Clinical pharmacology74 (PDF -268KB) Statistical75 (PDF -932KB) PREA
Bepotastine besilate - Bepreve Ista Pharmaceuticals, Inc. Medical76 (PDF -2MB) Clinical pharmacology77 (PDF -693KB) Statistical78 (PDF -696KB) PREA
Besifloxacin hydrochloride - Besivance Bausch & Lomb Medical79 (PDF -2MB)[*note for vision impaired users] Clinical pharmacology80 (PDF -684KB) Statistical81 (PDF -1MB)[*note for vision impaired users] PREA
Bicalutamide - Casodex AstraZeneca Pharmaceuticals Medical82 (PDF -1MB) Clinical pharmacology83 (PDF -579KB) Statistical84 (PDF -207KB) BPCA
Bivalirudin - Angiomax The Medicines Company Medical85 (PDF -717KB) Clinical pharmacology86 (PDF -2MB) None BPCA
Brimonidine tartrate - Timolol maleate - Combigan Allergen, Inc. Medical87 (PDF -2MB)[*note for vision impaired users] Clinical pharmacology88 (PDF -137KB)[*note for vision impaired users] Statistical89 (PDF -716KB)[*note for vision impaired users] PREA
Candesartan Cilexitil - Atacand Astra Zeneca Medical90 (PDF -1MB) Clinical pharmacology91 (PDF -991KB) Statistical92 (PDF -435KB) BPCA
Caspofungin acetate - Cancidas Merck Medical93 (PDF -3MB) Clinical pharmacology94 (PDF -465KB) Statistical95 (PDF -352KB) Both
Ciclesonide - Alvesco Aventis Medical96 (PDF -9MB) Clinical pharmacology97 (PDF -1MB) Statistical98 (PDF -300KB) PREA
Ciclesonide - Omnaris NYCOMED Medical99 (PDF -2MB) Clinical pharmacology100 (PDF -165KB) Statistical101 (PDF -158KB) PREA
Ciprofloxacin otic solution - Cetraxal Parexel International Medical102 (PDF -282KB) Clinical pharmacology103 (PDF -245KB) Statistical104 (PDF -511KB) PREA
Clindamycin phosphate/Benzoyl peroxide -Acanya Gel Dow Pharmaceutical Sciences, Inc. Medical105 (PDF -2MB) Clinical pharmacology106 (PDF -487KB) Statistical107 (PDF -836KB) PREA
Clonidine hydrochloride - Kapvay Shinoga Medical 108(PDF 1MB) Clinical pharmacology109 (PDF -225KB) Statistical 110(PDF -532MB) PREA
Clopidogrel bisulfate - Plavix Sanofi Aventis U.S. LLC Medical111 (PDF -478MB)
Clinical pharmacology112 (PDF -568KB)
Biopharmaeutic review113 (PDF -551KB)
Statistical114 (PDF -72KB) BPCA
Colchicine - Colcrys United Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc. Medical 115(PDF -51KB) Clinical pharmacology 116(PDF -51KB) None BPCA
Colesevelam hydrochloride - Welcho Daiichi-Sankyo Medical117 (PDF -8MB ) None Statistical118 (PDF -4MB) Both
Darunavir - Prezista Tibotec Medical119 (PDF -2MB) Clinical pharmacology120 (PDF - 949KB) None Both
Darunavir - Prezista Tibotec, Inc
Medical 121(PDF -1.8MB)
Medical 122(PDF -478KB)
Medical123 (PDF -286KB)
Clinical pharmacology124 (PDF -2.7MB)
Clinical pharmacology125 (PDF -793KB)
Desmopressin acetate Ferring Pharmaceuticals Inc. Medical126 (PDF -287KB) Clinical pharmacology127 (PDF -850KB ) None PREA
Dexmethylphenidate hydrochloride - Focalin XR Novartis Pharmaceuticals Corporation Medical128 (PDF -333KB) Clinical pharmacology129 (PDF -830KB) Statistical130 (PDF -151KB) PREA
Didanosine - Videx EC Bristol-Myers Squibb Company Medical131 (PDF -483KB) Clinical pharmacology132 (PDF -830KB) None PREA
Divalproex - Depakote ER and Depakote Sprinkle Abbott
Medical133 (PDF -100KB)
Medical134 (PDF -2MB)
Medical135 (PDF -1MB)
Medical136 (PDF -352KB)
Clinical pharmacology137 (PDF -100KB)
Clinical pharmacology138 (PDF -100KB)
None Both
Docetaxel - Taxotere Sanofi-Aventis Medical139 (PDF -1MB) Clinical pharmacology140 (PDF -671KB) Statistical141 (PDF -427KB) BPCA
Drospirenone/Ethinyl estradiol/Levomefolate calcium and Levomefolate calcium - Beyaz Bayer HealthCare Pharmaceuticals Inc. Medical142 (PDF -2MB) Clinical pharmacology143 (PDF -2MB) Statistical144 (PDF -399KB)
Statistical Addendum145 (PDF -22KB)
Drospirenone, Ethinyl estradiol, and Levomefolate calcium - Safyral Bayer HealthCare Pharmaceuticals Inc. Medical146 (PDF -2MB) Clinical pharmacology147 (PDF -1MB) Statistical 148(PDF -186KB) PREA
Eplerenone - Inspra GD Searle LLC Medical149 (PDF -1MB) Clinical pharmacology150 (PDF -798KB) Statistical151 (PDF -338KB) Both
Escitalopram - Lexapro Forest Laboratories, Inc. Medical152 (PDF -1MB) Clinical pharmacology153 (PDF -655KB) Statistical154 (PDF -772KB) BPCA
Esomeprazole magnesium - Nexium AstraZeneca Medical155 (PDF -1MB) Clinical pharmacology156 (PDF -1MB) Statistical157 (PDF -491KB) PREA
Esomeprazole magnesium - Nexium AstraZeneca Medical158 (PDF -1MB) Clinical pharmacology159 (PDF -2MB) Statistical160 (PDF -336KB) Both
Esomeprazole sodium - Nexium I.V. AstraZeneca LP Medical 161(PDF -644KB) Clinical pharmacology162 (PDF -2MB) None PREA
Estradiol valerate and estradiol valerate/dienogest - Natazia Bayer HealthCare Pharmaceuticals, Inc. Medical 163(PDF -1.9MB) Clinical pharmacology164 (PDF -494KB) Statistical 165(PDF -391KB) PREA
Etravirine - Intelence Janssen Products, L.P. Medical 166(PDF -945KB) Clinical pharmacology167 (PDF -2MB) None PREA
Everolimus - Afinitor Novartis Pharmaceuticals Corporation Medical168 (PDF -3MB) Clinical pharmacology169 (PDF -2MB) None BPCA
Ezetimbe/simvastatin - Vytorin Merck Schering-Plough Singapore Co., LLC Medical170 (PDF -2MB) Clinical pharmacology171 (PDF -200KB) Statistical172 (PDF -179KB) Both
Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC Medical173 (PDF -336KB) Clinical pharmacology174 (PDF -86KB) Statistical175 (PDF -375KB) Both
Famciclovir - Famvir Novartis Pharmaceutical Corporation Medical176 (PDF -779KB) Clinical pharmacology177 (PDF -354KB) None Both
Fluocinolone acetonide - Derma-Smoothe/FS Hill Dermaceuticals, Inc Medical178 (PDF -943KB) Clinical pharmacology179 (PDF -276KB) Statistical180 (PDF -507KB) PREA
Fluticasone propionate - Flovent HFA Glaxo Group LTD DBA GlaxoSmithkline Medical181 (PDF -334KB) Clinical pharmacology182 (PDF -890KB) None PREA
Fosamprenavir calcium - Lexiva ViiV Healthcare Company Medical 183(PDF -2MB) Clinical pharmacology184 (PDF -5MB) None Both
Fulvestrant - Faslodex AstraZeneca Pharmaceuticals LP Medical185 (PDF -194KB)
Medical 186(PDF -538KB)
Clinical pharmacology187 (PDF -437KB) Statistical 188(PDF -774KB) PREA
Gadobenate dimeglumine - MultiHance Bracco Diagnostics Inc. Medical189 (PDF -1MB) Clinical pharmacology190 (PDF -455KB) Statistical191 (PDF -545KB) PREA
Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc Medical 192(PDF -989KB) Clinical pharmacology193 (PDF -1MB) Statistical194 (PDF -375KB) PREA
Gatifloxacin - Zymar Allergan, Inc. Medical195 (PDF -573KB) Clinical pharmacology196 (PDF -60KB) Statistical197 (PDF -376KB) BPCA
Gatifloxacin - Zymaxid Allergan, Inc. Medical198 (PDF -3MB) Clinical pharmacology199 (PDF -119KB) Statistical200 (PDF -611KB) PREA
Granisetron hydrochloride - Kytril Hoffmann-La Roche Inc. Medica201l (PDF -409KB) Clinical pharmacology202 (PDF -17KB) Statistical203 (PDF -38KB) PREA
Guanfacine - Intuniv Shire Development, Inc. Medical204 (PDF -440KB) Clinical pharmacology205 (PDF -286KB) Statistical206 (PDF -493KB) PREA
Guanfacine hydrochloride - Intuniv Shire Development, Inc. Medical207 (PDF -465kb)
Medical208 (PDF -35KB)
Medical209 (PDF -118KB)
Clinical pharmacology210 (PDF -4MB) Statistical211 (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 Medical212 (PDF -676KB) Clinical pharmacology213 (PDF -37KB) Statistical214 (PDF -236KB) PREA
Helioblock SX - Anthelios 40 L’Oreal USA Medical215 (PDF -4MB) Clinical pharmacology216 (PDF -2MB) None PREA
Hydroxyprogesterone caproate - Makena Hologic, Inc Medical217 (PDF -439KB) Clinical pharmacology218 (PDF -36KB) Statistical219 (PDF -598KB) PREA
Imiquimod - Zyclara Cream, 3.75% Graceway Pharmaceuticals, LLC Medical220 (PDF -1.50MB) Clinical pharmacology221 (PDF -1.31MB) Statistical 222(PDF -326KB) PREA
Insulin Aspart - NovoLog Novo Nordisk, Inc. Medical223 (PDF -1MB) Clinical pharmacology224 (PDF -85KB) Statistical225 (PDF -159KB) PREA
Insulin glulisine - Apidra Sanofi-Aventis Medical226 (PDF -745KB) Clinical pharmacology227 (PDF -714KB) Statistical228 (PDF -391KB) PREA
Ivermectin - Sklice Sanofi-Topaz, Inc Medical229 (PDF -2MB) Clinical pharmacology230 (PDF -1MB) Statistical231 (PDF -909KB) PREA
Ixabepilone - Ixempra Bristol-Myers Squibb Company Medical232 (PDF -643KB) Clinical pharmacology233 (PDF -389KB) Statistical234 (PDF -447KB) BPCA
Lamotrigine - Lamictal XR GlaxoSmithKline Medical235 (PDF -52KB) Clinical pharmacology236 (PDF -3MB) Statistical237 (PDF -226KB) Both
Lamotrigine - Lamictal XR GlaxoSmithKline Medical238 (PDF -6 MB) None Statistical239 (PDF -472KB) PREA
Lamotrigine - Lamictal XR GlaxoSmithKline Medical 240(PDF -840KB) Clinical pharmacology241 (PDF -38KB) Statistical 242(PDF -391KB) PREA
Lansoprazole Oral Suspension - Prevacid TAP Pharmaceutical Products Medical243 (PDF -1,023KB) Clinical pharmacology244 (PDF -2MB) Statistical245 (PDF -54KB) BPCA
Levetiracetam - Keppra UCB, Inc. Medical246 (PDF -1MB) Clinical pharmacology247 (PDF -1MB) Statistical248 (PDF -2MB) Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical249 (PDF -97KB) Clinical pharmacology250 (PDF -668KB) None Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc Medical251 (PDF -1MB) Clinical pharmacology252 (PDF -419KB) None Both
Levofloxacin - Levaquin Ortho McNeil Janssen Pharmaceuticals Inc Medical253 (PDF -239KB) Clinical pharmacology254 (PDF -828KB) Statistical255 (PDF -39KB) PREA
Levonorgestrel-releasing intrauterine system - Mirena Bayer HealthCare Pharmaceuticals Medical256 (PDF -1MB) Clinical pharmacology257 (PDF -358KB) Statistical258 (PDF -71KB) PREA
Levonorgestrel - Plan B one step Duramed Medical 259(PDF -116KB)
Medical 260(PDF -315KB)
Clinical pharmacology261 (PDF -47KB)
Clinical pharmacology262 (PDF -72KB)
Statistical263 (PDF -26KB) PREA
Lidocaine hydrochloride - Akten Akorn, Inc. Medical264 (PDF -120KB) Clinical pharmacology265 (PDF -57KB) Statistical266 (PDF -292KB) PREA
Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical267 (PDF -2MB) None (PDF) Statistical268 (PDF -676KB) PREA
Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical 269(PDF -688KB) None Statistical 270(PDF -792KB) PREA
Lopinavir/ritonavir - Kaletra Abbott Medical271 (PDF -3MB) Clinical pharmacology272 (PDF -904KB) None Both
Loteprednol etabonate 0.5% and tobramycin 0.3% - Zylet Bausch & Lomb Medical273 (PDF -37MB)
Medical274 (PDF -24KB)
None None PREA
Loteprednol etabonate and tobramycin ophthalmic suspension - Zylet Bausch & Lomb, Incorporated Medical 275(PDF -84KB) None None BOTH
Mannitol - Aridol Pharmaxis Ltd Medical276 (PDF - 396KB) Clinical pharmacology277 (PDF -226KB) Statistical278 (PDF -2MB) PREA
Methylphenidate hydrochloride - Quillivant NextWave Pharmaceuticals, Inc.
Medical 279(PDF -201KB)
Memo 280(PDF -320KB)
Clinical pharmacology282 (PDF -225)
Statistical 283(PDF -241KB PREA
Methylphenidate Transdermal System - Daytrana Shire Pharmaceuticals Medical284 (PDF -2MB)
Medical285 (PDF -36KB)
Clinical pharmacology286 (PDF -568KB) Statistical287 (PDF -162KB) PREA
Mometasone furoate - Asmanex Twisthaler Schering Plough Corporation Medical288 (PDF -4MB) Clinical pharmacology289 (PDF -595KB) Statistical290 (PDF -548KB)
Statistical291 (PDF -250KB)
Mometasone furoate - Nasonex Schering-Plough Medical292 (PDF 155KB) None Statistical293 (PDF -627KB) PREA
Mometasone furoate monohydrate - Nasonex Schering-Plough Medical 294(PDF 435KB) Clinical pharmacology295 (PDF -143KB) Statistical 296(PDF -176KB) PREA
Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical297 (PDF -1MB) Clinical pharmacology298 (PDF -2MB) Statistical299 (PDF -433KB) PREA
Montelukast sodium - Singulair Merck Sharp & Dohme Corp. Medical 300(PDF -2MB) Clinical pharmacology301 (PDF -74KB) Statistical 302(PDF -94KB) PREA
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF Alcon Research Ltd. Medical303 (PDF -615KB) Clinical pharmacology304 (PDF -235KB) Statistical305 (PDF -580KB) PREA
Nevirapine - Viramune Boehringer Ingelheim Medical306 (PDF -1MB) Clinical pharmacology307 (PDF -926KB) None PREA
Nitric Oxide - INOmax INO Therapeutics Medical308 (PDF -1MB) Clinical pharmacology309 (PDF -45KB) Statistical310 (PDF -612KB) Both
Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe Warner Chilcott Company, Inc. Medical311 (PDF -166KB) Clinical pharmacology312 (PDF -50KB) Statistical313 (PDF -31KB) PREA
Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBD Warner Chilcott, LLC Medical314 (PDF -505KB) Clinical pharmacology315 (PDF -21KB) Statistical316 (PDF -106KB) PREA
Olanzapine - Zyprexa Eli Lilly Medical 317(PDF -41KB)
Medical 318(PDF -40KB)
Medical 319(PDF -62KB)
Medical320 (PDF -2MB)
Medical321 (PDF -604KB)
BPCA Summary322 (PDF -76KB
Clinical pharmacology323 (PDF -962KB) Statistical324 (PDF -452KB)
Statistical Addendum325 (PDF -159KB)
Olmesartan Medoxomil - Benicar Daiichi Sankyo Medical326 (PDF -2MB) Clinical pharmacology327 (PDF -964KB) Statistical328 (PDF -527KB) Both
Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical329 (PDF -3MB) Clinical pharmacology330 (PDF -2MB) Statistical331 (PDF -3MB) PREA
Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical 332(PDF -3.2MB) Clinical pharmacology333 (PDF -791KB) Statistical 334(PDF -315KB) Both
Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical335 (PDF -1MB) Clinical pharmacology336 (PDF -845KB) Statistical337 (PDF -703KB) PREA
Omeprazole magnesium - Prilosec AstraZeneca LLP Medical338 (PDF -318KB) Clinical pharmacology339 (PDF -869KB) None PREA
Paliperidone - Invega Ortho-McNeil-Janssen Pharmaceuticals, Inc. Medical 340(PDF -289MB) Clinical pharmacology341 (PDF -447KB) Statistical 342(PDF -252KB) PREA
Pancrelipase - Creon Abbott Products Inc. Medical 343(PDF -702KB) Clinical pharmacology344 (PDF -58KB) Statistical 345(PDF -84KB) PREA
Pancrelipase - Pancreaze Johnson & Johnson Pharmaceutical Research & Development, L.L.C Medical346 (PDF -2MB) Clinical pharmacology347 (PDF -546KB) Statistical348 (PDF -326KB) PREA
Pancrelipase - Pertyze Digestive Care, Inc. Medical 349(PDF -4MB) Clinical pharmacology350 (PDF -1MB) Statistical 351(PDF -736KB) PREA
Pancrelipase - Ultrase Axcan Scandipharm, Inc. Medical352 (PDF -4MB)
Safety353 (PDF -230KB)
Safety354 (PDF -119KB)
Clinical pharmacology355 (PDF -116KB)
Clinical pharmacology356 (PDF -1MB)
Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd. Medical357 (PDF -2MB) Clinical pharmacology358 (PDF -502KB) Statistical359 (PDF -377KB) PREA
Pantoprazole sodium - Protonix Wyeth Pharmaceuticals, Inc. DD Summary Review360 (PDF -907KB)
CDTL Review361 (PDF -597KB)
Medical362 (PDF -11MB)
Medical Addendum363 (PDF -260KB)
Clinical pharmacology364 (PDF -8MB) Statistical365 (PDF -721KB) Both
Pegfilgrastim - Neulasta Amgen Medical366 (PDF -965KB) [*note for vision impaired users] Clinical pharmacology367 (PDF -945KB) [*note for vision impaired users] None PREA
Peginterferon - PegIntron Schering-Plough Research Institute Medical368 (PDF -937KB) Clinical pharmacology369 (PDF -825KB) Statistical370 (PDF -1MB) PREA
Pemetrexed disodium - Alimta Eli Lilly and Company Medical371 (PDF -632KB) Clinical pharmacology372 (PDF -207KB) Statistical373 (PDF -364KB) BPCA
Phentolamine - OraVerse Novalar Pharmaceuticals, Inc. Medical374 (PDF -4MB) Clinical pharmacology375 (PDF -1MB) Statistical376 (PDF -762KB) PREA
Pilocarpine hydrochloride - Isopto Carpine Alcon Research, Ltd. Medical377 (PDF -4MB) Clinical pharmacology378 (PDF -462KB) Statistical379 (PDF -1MB) PREA
Quetiapine fumarate - Seroquel Astra-Zeneca Medical380 (PDF -3MB)
Medical Addendum381 (PDF -700KB)
Clinical pharmacology382 (PDF -2MB) Statistical383 (PDF -776KB) Both
Rabeprazole sodium - Aciphex Eisai Medical Research Inc. Medical384 (PDF -611KB) Clinical pharmacology385 (PDF -682KB) None PREA
Retapamulin - Altabax GlaxoSmithKline Medical386 (PDF -359KB) Clinical pharmacology387 (PDF -408KB) None PREA
Ribavirin / Peginterferon alfa-2a - Copegus / Pegasys Hoffmann-La Roche Inc Medical 388(PDF -1MB) Clinical pharmacology389 (PDF -69KB) Medical 390(PDF -1MB) PREA
Risedronate sodium - Actonel Procter & Gamble Pharmaceuticals, Inc Medical391 (PDF -437KB) Clinical pharmacology392 (PDF -636KB) Statistical393 (PDF -255KB) Both
Rizatriptan - Maxalt-MLT Merck Research Laboratories Medical 394(PDF -2.6MB)
Medical 395(PDF -659KB)
CTDL Review396 (PDF -221KB)
CTDL Addendum397 (PDF -112KB)
DD Memo398 (PDF -22KB)
Clinical pharmacology399 (PDF -2MB) Statistical 400(PDF -374KB)
Statistical 401(PDF -381KB)
Rocuronium bromide - Zemuron Organon USA, Inc. Medical402 (PDF -1MB) Clinical pharmacology403 (PDF -877KB) None Both
Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP Medical404 (PDF -3MB) Clinical pharmacology405 (PDF -603KB) Statistical406 (PDF -482KB) Both
Saquinavir mesylate - Invirase Hoffmann-La Roche Inc. Medical407 (PDF -366 KB) Clinical pharmacology408 (PDF -706KB) Statistical409 (PDF -446KB) PREA
Somatropin - Accretropin Cangene Corporation Medical410 (PDF -3MB) Clinical pharmacology411 (PDF -7MB) Statistical412 (PDF -2MB) PREA
Spinosad - Natroba Suspension, 0.9% ParaPRO Medical413 (PDF -278KB) Clinical pharmacology414 (PDF -50KB) Statistical415 (PDF -46KB) Statistical416 (PDF -23KB) PREA
Sterile Intraocular - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical417 (PDF -8MB) Clinical pharmacology418 (PDF -85KB) None PREA
Tamsulosin hydrochloride - Flomax Boehringer Ingelheim Medical419 (PDF -3MB) Clinical pharmacology420 (PDF -1MB) Statistical421 (PDF -253KB) BPCA
Technetium Tc99m - Cardiolite Bristol Myers Squibb Medical422 (PDF -561KB) Clinical pharmacology423 (PDF -571KB) Statistical424 (PDF -357KB) BPCA
Temsirolimus - Torisel Wyeth Pharmaceuticals, a Pfizer Company Medical 425(PDF -2MB) Clinical pharmacology426 (PDF -2MB) Statistical 427(PDF -250KB) BPCA
Tenofovir disoproxil fumarate - Viread Gilead Medical428 (PDF -3MB) Clinical pharmacology429 (PDF -474KB) Statistical430 (PDF -1MB) PREA
Tenofovir disoproxil fumarate - Viread Gilead Sciences, Incorporated Medical431 (PDF -647KB) Clinical pharmacology432 (PDF -1.66MB) Statistical433 (PDF -774KB) BPCA
Terbinafine - Lamisil Novartis Pharmaceuticals Corp. Medical434 (PDF -6MB)[*note for vision impaired users] Clinical pharmacology435 (PDF -3MB)[*note for vision impaired users] Statistical436 (PDF -2MB)[*note for vision impaired users] BPCA
Tipranavir - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc. Medical437 (PDF -2MB) Clinical pharmacology438 (PDF -2MB) Statistical439 (PDF -589KB) Both
Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group Medical 440(PDF -1.4MB) Clinical pharmacology441 (PDF 670KB) Statistical 442(PDF -543KB) PREA
Topiramate - Topamaxdisclaimer icon443 Janssen Pharmaceuticals, Inc. Medical 444(PDF -7MB) Clinical pharmacology445 (PDF -1MB) None PREA
Topiramate - Topamax Johnson and Johnson Pharmaceutical
Research & Development L.L.C.
Medical446 (PDF -3MB) Clinical pharmacology447 (PDF -986KB) None BPCA
Triamcinolone acetonide - Triesence Alcon, Inc. Medical448 (PDF -2MB) Clinical pharmacology449 (PDF -802KB) Statistical450 (PDF -402KB) PREA
Triamcinolone acetonide - Nasacort AQ Sanofi Aventis Medical451 (PDF -882KB) Clinical pharmacology452 (PDF -810KB) Statistical453 (PDF -615KB) PREA
Ulipristal acetate - Ella Laboratoire HRA Pharma Medical 454(PDF -1MB) Clinical pharmacology455 (PDF -2MB)
Clinical pharmacology Addendum456 (PDF -46KB)
Statistical 457(PDF -3MB) PREA
Valacyclovir hydrochloride - Valtrex GlaxoSmithKline Medical458 (PDF -719KB) Clinical pharmacology459 (PDF -506KB)
Clinical pharmacology460 (PDF -646KB)
None Both
Valganciclovir hydrochloride - Valcyte Hoffmann-La Roche, Inc. Medical461 (PDF -1MB)
Medical462 (PDF -358KB)
Clinical pharmacology463 (PDF -179KB)
Clinical pharmacology464 (PDF -2MB)
None Both
Valsartan - Diovan Novartis Medical465 (PDF -1MB) Clinical pharmacology466 (PDF -10MB) Statistical467 (PDF -2MB) BPCA
Zidovudine, ZDV - Retrovir GlaxoSmithKline Medical468 (PDF -767KB) Clinical pharmacology469 (PDF -686KB) None PREA
Zidovudine - Retrovir ViiV Healthcare Co Medical470 (PDF -757KB) Clinical pharmacology471 (PDF -285) None PREA
Ziprasidone - Geodon Pfizer Medical472 (PDF -2MB)
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