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
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) | PREA |
| 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) | None | BPCA |
| 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 | 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) | PREA |
| 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 pharmacology281 (PDF -67) 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) | PREA |
| 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) BPCA Summary322 (PDF -76KB | Clinical pharmacology323 (PDF -962KB) | Statistical324 (PDF -452KB) Statistical Addendum325 (PDF -159KB) | Both |
| 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) | None | PREA |
| 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) | BPCA |
| 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 - Topamax 443 | 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) Medical Addendum473 (PDF -63KB) | Clinical pharmacology474 (PDF -2MB) | Statistical475 (PDF -359KB) | PREA |
| Zoledronic acid - Zometa | Novartis Pharmaceutical Corp. | Medical476 (PDF -2MB) | Clinical pharmacology477 (PDF -615KB) | Statistical478 (PDF -422KB) | BPCA |
| Zolmitriptan - Zomig | AstraZeneca | Medical479 (PDF -2MB) | Clinical pharmacology480 (PDF -703KB) | Statistical481 (PDF -368KB) | PREA |
* Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.
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