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 = 20
Total Number of Products Studied under PREA = 91
Total Number of Products Studied under Both = 28

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

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 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
Azithromycin - Zmax Pfizer Medical61 (PDF -76KB) Clinical pharmacology62 (PDF -67KB) None PREA
Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical63 (PDF -4 MB) Clinical pharmacology64 (PDF -49KB) None PREA
Benzyl Alcohol - Ulesfia Asphyxiator Sciele Pharma, Inc Medical65 (PDF -299KB) Clinical pharmacology66 (PDF -268KB) Statistical67 (PDF -932KB) PREA
Bepotastine besilate - Bepreve Ista Pharmaceuticals, Inc. Medical68 (PDF -2MB) Clinical pharmacology69 (PDF -693KB) Statistical70 (PDF -696KB) PREA
Besifloxacin hydrochloride - Besivance Bausch & Lomb Medical71 (PDF -2MB)[*note for vision impaired users] Clinical pharmacology72 (PDF -684KB) Statistical73 (PDF -1MB)[*note for vision impaired users] PREA
Bicalutamide - Casodex AstraZeneca Pharmaceuticals Medical74 (PDF -1MB) Clinical pharmacology75 (PDF -579KB) Statistical76 (PDF -207KB) BPCA
Bivalirudin - Angiomax The Medicines Company Medical77 (PDF -717KB) Clinical pharmacology78 (PDF -2MB) None BPCA
Brimonidine tartrate - Timolol maleate - Combigan Allergen, Inc. Medical79 (PDF -2MB)[*note for vision impaired users] Clinical pharmacology80 (PDF -137KB)[*note for vision impaired users] Statistical81 (PDF -716KB)[*note for vision impaired users] PREA
Candesartan Cilexitil - Atacand Astra Zeneca Medical82 (PDF -1MB) Clinical pharmacology83 (PDF -991KB) Statistical84 (PDF -435KB) BPCA
Caspofungin acetate - Cancidas Merck Medical85 (PDF -3MB) Clinical pharmacology86 (PDF -465KB) Statistical87 (PDF -352KB) Both
Ciclesonide - Alvesco Aventis Medical88 (PDF -9MB) Clinical pharmacology89 (PDF -1MB) Statistical90 (PDF -300KB) PREA
Ciclesonide - Omnaris NYCOMED Medical91 (PDF -2MB) Clinical pharmacology92 (PDF -165KB) Statistical93 (PDF -158KB) PREA
Ciprofloxacin otic solution - Cetraxal Parexel International Medical94 (PDF -282KB) Clinical pharmacology95 (PDF -245KB) Statistical96 (PDF -511KB) PREA
Clindamycin phosphate/Benzoyl peroxide -Acanya Gel Dow Pharmaceutical Sciences, Inc. Medical97 (PDF -2MB) Clinical pharmacology98 (PDF -487KB) Statistical99 (PDF -836KB) PREA
Clonidine hydrochloride - Clonicel Shinoga Medical 100(PDF 1MB) Clinical pharmacology101 (PDF -225KB) Statistical 102(PDF -532MB) PREA
Clopidogrel bisulfate - Plavix Sanofi Aventis U.S. LLC Medical103 (PDF -478MB) Clinical pharmacology104 (PDF -568KB)
Biopharmaeutic review105 (PDF -551KB)
 Statistical106 (PDF -72KB) BPCA
Colesevelam hydrochloride - Welcho Daiichi-Sankyo Medical107 (PDF -8MB ) None Statistical108 (PDF -4MB) Both
Darunavir - Prezista Tibotec Medical109 (PDF -2MB) Clinical pharmacology110 (PDF - 949KB) None Both
Desmopressin acetate Ferring Pharmaceuticals Inc. Medical111 (PDF -287KB) Clinical pharmacology112 (PDF -850KB ) None PREA
Dexmethylphenidate hydrochloride - Focalin XR Novartis Pharmaceuticals Medical113 (PDF -725KB) Clinical pharmacology114 (PDF -121KB) Statistical115 (PDF -624KB) BPCA
Dexmethylphenidate hydrochloride - Focalin XR Novartis Pharmaceuticals Corporation Medical116 (PDF -333KB) Clinical pharmacology117 (PDF -830KB) Statistical118 (PDF -151KB) PREA
Didanosine - Videx EC Bristol-Myers Squibb Company Medical119 (PDF -483KB) Clinical pharmacology120 (PDF -830KB) None PREA
Divalproex - Depakote ER and Depakote Sprinkle Abbott Medical121 (PDF -100KB)
Medical122 (PDF -2MB)
Medical123 (PDF -1MB)
Medical124 (PDF -352KB)
 Clinical pharmacology125 (PDF -100KB)
Clinical pharmacology126 (PDF -100KB)
 None Both
Docetaxel - Taxotere Sanofi-Aventis Medical127 (PDF -1MB) Clinical pharmacology128 (PDF -671KB) Statistical129 (PDF -427KB) BPCA
Drospirenone, Ethinyl estradiol, and Levomefolate calcium - Safyral Bayer HealthCare Pharmaceuticals Inc. Medical130 (PDF -2MB) Clinical pharmacology131 (PDF -1MB) Statistical 132(PDF -186KB) PREA
Eplerenone - Inspra GD Searle LLC Medical133 (PDF -1MB) Clinical pharmacology134 (PDF -798KB) Statistical135 (PDF -338KB) Both
Escitalopram - Lexapro Forest Laboratories, Inc. Medical136 (PDF -1MB) Clinical pharmacology137 (PDF -655KB) Statistical138 (PDF -772KB) BPCA
Esomeprazole magnesium - Nexium AstraZeneca Medical139 (PDF -1MB) Clinical pharmacology140 (PDF -1MB) Statistical141 (PDF -491KB) PREA
Esomeprazole magnesium - Nexium AstraZeneca Medical142 (PDF -1MB) Clinical pharmacology143 (PDF -2MB) Statistical144 (PDF -336KB) Both
Esomeprazole sodium - Nexium I.V. AstraZeneca LP Medical 145(PDF -644KB) Clinical pharmacology146 (PDF -2MB) None PREA
Ezetimbe/simvastatin - Vytorin Merck Schering-Plough Singapore Co., LLC Medical147 (PDF -2MB) Clinical pharmacology148 (PDF -200KB) Statistical149 (PDF -179KB) Both
Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC Medical150 (PDF -336KB) Clinical pharmacology151 (PDF -86KB) Statistical152 (PDF -375KB) Both
Famciclovir - Famvir Novartis Pharmaceutical Corporation Medical153 (PDF -779KB) Clinical pharmacology154 (PDF -354KB) None Both
Fluocinolone acetonide - Derma-Smoothe/FS Hill Dermaceuticals, Inc Medical155 (PDF -943KB) Clinical pharmacology156 (PDF -276KB) Statistical157 (PDF -507KB) PREA
Fluticasone propionate - Flovent HFA Glaxo Group LTD DBA GlaxoSmithkline Medical158 (PDF -334KB) Clinical pharmacology159 (PDF -890KB) None PREA
Fulvestrant - Faslodex AstraZeneca Pharmaceuticals LP Medical160 (PDF -194KB)
Medical 161(PDF -538KB) Clinical pharmacology162 (PDF -437KB) Statistical 163(PDF -774KB) PREA
Gadobenate dimeglumine - MultiHance Bracco Diagnostics Inc. Medical164 (PDF -1MB) Clinical pharmacology165 (PDF -455KB) Statistical166 (PDF -545KB) PREA
Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc Medical 167(PDF -989KB) Clinical pharmacology168 (PDF -1MB) Statistical169 (PDF -375KB) PREA
Gatifloxacin - Zymar Allergan, Inc. Medical170 (PDF -573KB) Clinical pharmacology171 (PDF -60KB) Statistical172 (PDF -376KB) BPCA
Gatifloxacin - Zymaxid Allergan, Inc. Medical173 (PDF -3MB) Clinical pharmacology174 (PDF -119KB) Statistical175 (PDF -611KB) PREA
Granisetron hydrochloride - Kytril Hoffmann-La Roche Inc. Medica176l (PDF -409KB) Clinical pharmacology177 (PDF -17KB) Statistical178 (PDF -38KB) PREA
Guanfacine - Intuniv Shire Development, Inc. Medical179 (PDF -440KB) Clinical pharmacology180 (PDF -286KB) Statistical181 (PDF -493KB) PREA
Guanfacine hydrochloride - Intuniv Shire Development, Inc. Medical182 (PDF -465kb)
Medical183 (PDF -35KB)
Medical184 (PDF -118KB) Clinical pharmacology185 (PDF -4MB) Statistical186 (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 Medical187 (PDF -676KB) Clinical pharmacology188 (PDF -37KB) Statistical189 (PDF -236KB) PREA
Helioblock SX - Anthelios 40 L’Oreal USA Medical190 (PDF -4MB) Clinical pharmacology191 (PDF -2MB) None PREA
Hydroxyprogesterone caproate - Makena Hologic, Inc Medical192 (PDF -439KB) Clinical pharmacology193 (PDF -36KB) Statistical194 (PDF -598KB) PREA
Imiquimod - Zyclara Cream, 3.75%  Graceway Pharmaceuticals, LLC Medical195 (PDF -1.50MB) Clinical pharmacology196 (PDF -1.31MB) Statistical 197(PDF -326KB) PREA
Insulin Aspart - NovoLog Novo Nordisk, Inc. Medical198 (PDF -1MB) Clinical pharmacology199 (PDF -85KB) Statistical200 (PDF -159KB) PREA
Insulin glulisine - Apidra Sanofi-Aventis Medical201 (PDF -745KB) Clinical pharmacology202 (PDF -714KB) Statistical203 (PDF -391KB) PREA
Lamotrigine - Lamictal XR GlaxoSmithKline Medical204 (PDF -52KB) Clinical pharmacology205 (PDF -3MB) Statistical206 (PDF -226KB) Both
Lamotrigine - Lamictal XR GlaxoSmithKline Medical207 (PDF -6 MB) None Statistical208 (PDF -472KB) PREA
Lamotrigine - Lamictal XR GlaxoSmithKline Medical 209(PDF -840KB) Clinical pharmacology210 (PDF -38KB) Statistical 211(PDF -391KB) PREA
Lansoprazole Oral Suspension - Prevacid TAP Pharmaceutical Products Medical212 (PDF -1,023KB) Clinical pharmacology213 (PDF -2MB) Statistical214 (PDF -54KB) BPCA
Levetiracetam - Keppra UCB, Inc. Medical215 (PDF -1MB) Clinical pharmacology216 (PDF -1MB) Statistical217 (PDF -2MB) Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical218 (PDF -97KB) Clinical pharmacology219 (PDF -668KB) None Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc Medical220 (PDF -1MB) Clinical pharmacology221 (PDF -419KB) None Both
Levofloxacin - Levaquin Ortho McNeil Janssen Pharmaceuticals Inc Medical222 (PDF -239KB) Clinical pharmacology223 (PDF -828KB) Statistical224 (PDF -39KB) PREA
Levonorgestrel-releasing intrauterine system - Mirena Bayer HealthCare Pharmaceuticals Medical225 (PDF -1MB) Clinical pharmacology226 (PDF -358KB) Statistical227 (PDF -71KB) PREA
Levonorgestrel - Plan B one step Duramed Medical 228(PDF -116KB)
Medical 229(PDF -315KB) Clinical pharmacology230 (PDF -47KB)
Clinical pharmacology231 (PDF -72KB) Statistical232 (PDF -26KB) PREA
Lidocaine hydrochloride - Akten Akorn, Inc. Medical233 (PDF -120KB) Clinical pharmacology234 (PDF -57KB) Statistical235 (PDF -292KB) PREA
Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical236 (PDF -2MB) None (PDF) Statistical237 (PDF -676KB) PREA
Lopinavir/ritonavir - Kaletra Abbott Medical238 (PDF -3MB) Clinical pharmacology239 (PDF -904KB) None Both
Loteprednol etabonate 0.5% and Tobramycin 0.3% - Zylet Bausch & Lomb Medical240 (PDF -37MB)
Medical241 (PDF -24KB) None None PREA
Loteprednol etabonate and Tobramycin ophthalmic suspension - Zylet Bausch & Lomb, Incorporated Medical 242(PDF -84) None None PREA
Mannitol - Aridol Pharmaxis Ltd Medical243 (PDF - 396KB) Clinical pharmacology244 (PDF -226KB) Statistical245 (PDF -2MB) PREA
Methylphenidate Transdermal System - Daytrana Shire Pharmaceuticals Medical246 (PDF -2MB)
Medical247 (PDF -36KB) Clinical pharmacology248 (PDF -568KB) Statistical249 (PDF -162KB) PREA
Mometasone furoate - Asmanex Twisthaler Schering Plough Corporation Medical250 (PDF -4MB) Clinical pharmacology251 (PDF -595KB) Statistical252 (PDF -548KB)
Statistical253 (PDF -250KB) PREA
Mometasone furoate - Nasonex Schering-Plough Medical254 (PDF 155KB) None Statistical255 (PDF -627KB) PREA
Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical256 (PDF -1MB) Clinical pharmacology257 (PDF -2MB) Statistical258 (PDF -433KB) PREA
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF Alcon Research Ltd. Medical259 (PDF -615KB) Clinical pharmacology260 (PDF -235KB) Statistical261 (PDF -580KB) PREA
Nevirapine - Viramune Boehringer Ingelheim Medical262 (PDF -1MB) Clinical pharmacology263 (PDF -926KB) None PREA
Nitric Oxide - INOmax INO Therapeutics Medical264 (PDF -1MB) Clinical pharmacology265 (PDF -45KB) Statistical266 (PDF -612KB) Both
Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe Warner Chilcott Company, Inc. Medical267 (PDF -166KB) Clinical pharmacology268 (PDF -50KB) Statistical269 (PDF -31KB) PREA
Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBD Warner Chilcott, LLC Medical270 (PDF -505KB) Clinical pharmacology271 (PDF -21KB) Statistical272 (PDF -106KB) PREA
Olanzapine - Zyprexa Eli Lilly Medical 273(PDF -41KB)
Medical 274(PDF -40KB)
Medical 275(PDF -62KB)
Medical276 (PDF -2MB)
Medical277 (PDF -604KB)
BPCA Summary278 (PDF -76KB
 Clinical pharmacology279 (PDF -962KB) Statistical280 (PDF -452KB)
Statistical Addendum281 (PDF -159KB) Both
Olmesartan Medoxomil - Benicar Daiichi Sankyo Medical282 (PDF -2MB) Clinical pharmacology283 (PDF -964KB) Statistical284 (PDF -527KB) Both
Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical285 (PDF -3MB) Clinical pharmacology286 (PDF -2MB) Statistical287 (PDF -3MB) PREA
Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical288 (PDF -1MB) Clinical pharmacology289 (PDF -845KB) Statistical290 (PDF -703KB) PREA
Omeprazole magnesium - Prilosec AstraZeneca LLP Medical291 (PDF -318KB) Clinical pharmacology292 (PDF -869KB) None PREA
Paliperidone - Invega Ortho-McNeil-Janssen Pharmaceuticals, Inc. Medical 293(PDF -289MB) Clinical pharmacology294 (PDF -447KB) Statistical 295(PDF -252KB) PREA
Pancrelipase - Creon  Abbott Products Inc. Medical 296(PDF -702KB) Clinical pharmacology297 (PDF -58KB) Statistical 298(PDF -84KB) PREA
Pancrelipase - Pancreaze Johnson & Johnson Pharmaceutical Research & Development, L.L.C Medical299 (PDF -2MB) Clinical pharmacology300 (PDF -546KB) Statistical301 (PDF -326KB) PREA
Pancrelipase - Ultrase Axcan Scandipharm, Inc. Medical302 (PDF -4MB)
Safety303 (PDF -230KB)
Safety304 (PDF -119KB) Clinical pharmacology305 (PDF -116KB)
Clinical pharmacology306 (PDF -1MB)
 None PREA
Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd. Medical307 (PDF -2MB) Clinical pharmacology308 (PDF -502KB) Statistical309 (PDF -377KB) PREA
Pantoprazole sodium - Protonix Wyeth Pharmaceuticals, Inc. DD Summary Review310 (PDF -907KB)
CDTL Review311 (PDF -597KB)
Medical312 (PDF -11MB)
Medical Addendum313 (PDF -260KB) Clinical pharmacology314 (PDF -8MB) Statistical315 (PDF -721KB) Both
Pegfilgrastim - Neulasta Amgen Medical316 (PDF -965KB) [*note for vision impaired users] Clinical pharmacology317 (PDF -945KB) [*note for vision impaired users] None PREA
Peginterferon - PegIntron Schering-Plough Research Institute Medical318 (PDF -937KB) Clinical pharmacology319 (PDF -825KB) Statistical320 (PDF -1MB) PREA
Pemetrexed disodium - Alimta Eli Lilly and Company Medical321 (PDF -632KB) Clinical pharmacology322 (PDF -207KB) Statistical323 (PDF -364KB) BPCA
Phentolamine - OraVerse Novalar Pharmaceuticals, Inc. Medical324 (PDF -4MB) Clinical pharmacology325 (PDF -1MB) Statistical326 (PDF -762KB) PREA
Pilocarpine hydrochloride - Isopto Carpine Alcon Research, Ltd. Medical327 (PDF -4MB) Clinical pharmacology328 (PDF -462KB) Statistical329 (PDF -1MB) PREA
Quetiapine fumarate - Seroquel Astra-Zeneca Medical330 (PDF -3MB)
Medical Addendum331 (PDF -700KB) Clinical pharmacology332 (PDF -2MB) Statistical333 (PDF -776KB) PREA
Rabeprazole sodium - Aciphex Eisai Medical Research Inc. Medical334 (PDF -611KB) Clinical pharmacology335 (PDF -682KB) None PREA
Retapamulin - Altabax GlaxoSmithKline Medical336 (PDF -359KB) Clinical pharmacology337 (PDF -408KB) None PREA
Risedronate sodium - Actonel Procter & Gamble Pharmaceuticals, Inc Medical338 (PDF -437KB) Clinical pharmacology339 (PDF -636KB) Statistical340 (PDF -255KB) Both
Rocuronium bromide - Zemuron Organon USA, Inc. Medical341 (PDF -1MB) Clinical pharmacology342 (PDF -877KB) None Both
Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP Medical343 (PDF -3MB) Clinical pharmacology344 (PDF -603KB) Statistical345 (PDF -482KB) Both
Saquinavir mesylate - Invirase Hoffmann-La Roche Inc. Medical346 (PDF -366 KB) Clinical pharmacology347 (PDF -706KB) Statistical348 (PDF -446KB) PREA
Somatropin - Accretropin Cangene Corporation Medical349 (PDF -3MB) Clinical pharmacology350 (PDF -7MB) Statistical351 (PDF -2MB) PREA
Spinosad - Natroba Suspension, 0.9% ParaPRO Medical352 (PDF -278KB) Clinical pharmacology353 (PDF -50KB) Statistical354 (PDF -46KB)   Statistical355 (PDF -23KB)    PREA
Sterile Intraocular - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical356 (PDF -8MB) Clinical pharmacology357 (PDF -85KB) None PREA
Tamsulosin hydrochloride - Flomax Boehringer Ingelheim Medical358 (PDF -3MB) Clinical pharmacology359 (PDF -1MB) Statistical360 (PDF -253KB) BPCA
Technetium Tc99m - Cardiolite Bristol Myers Squibb Medical361 (PDF -561KB) Clinical pharmacology362 (PDF -571KB) Statistical363 (PDF -357KB) BPCA
Tenofovir disoproxil fumarate - Viread Gilead Medical364 (PDF -3MB) Clinical pharmacology365 (PDF -474KB) Statistical366 (PDF -1MB) PREA
Terbinafine - Lamisil Novartis Pharmaceuticals Corp. Medical367 (PDF -6MB)[*note for vision impaired users] Clinical pharmacology368 (PDF -3MB)[*note for vision impaired users] Statistical369 (PDF -2MB)[*note for vision impaired users] BPCA
Tipranavir - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc. Medical370 (PDF -2MB) Clinical pharmacology371 (PDF -2MB) Statistical372 (PDF -589KB) Both
Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group Medical 373(PDF -1.4MB) Clinical pharmacology374 (PDF 670KB) Statistical 375(PDF -543KB) PREA
Topiramate - Topamax  Janssen Pharmaceuticals, Inc. Medical 376(PDF -7MB) Clinical pharmacology377 (PDF -1MB) None PREA
Topiramate - Topamax Johnson and Johnson Pharmaceutical
Research & Development L.L.C. Medical378 (PDF -3MB) Clinical pharmacology379 (PDF -986KB) None BPCA
Triamcinolone acetonide - Triesence Alcon, Inc. Medical380 (PDF -2MB) Clinical pharmacology381 (PDF -802KB) Statistical382 (PDF -402KB) PREA
Triamcinolone acetonide - Nasacort AQ Sanofi Aventis Medical383 (PDF -882KB) Clinical pharmacology384 (PDF -810KB) Statistical385 (PDF -615KB) PREA
Valacyclovir hydrochloride - Valtrex GlaxoSmithKline Medical386 (PDF -719KB) Clinical pharmacology387 (PDF -506KB)
Clinical pharmacology388 (PDF -646KB) None Both
Valganciclovir hydrochloride - Valcyte Hoffmann-La Roche, Inc. Medical389 (PDF -1MB)
Medical390 (PDF -358KB) Clinical pharmacology391 (PDF -179KB)
Clinical pharmacology392 (PDF -2MB) None Both
Valsartan - Diovan Novartis Medical393 (PDF -1MB) Clinical pharmacology394 (PDF -10MB) Statistical395 (PDF -2MB) BPCA
Zidovudine, ZDV - Retrovir GlaxoSmithKline Medical396 (PDF -767KB) Clinical pharmacology397 (PDF -686KB) None PREA
Zidovudine - Retrovir ViiV Healthcare Co Medical398 (PDF -757) Clinical pharmacology399 (PDF -285) None PREA
Ziprasidone - Geodon Pfizer Medical400 (PDF -2MB)
Medical Addendum401 (PDF -63KB) Clinical pharmacology402 (PDF -2MB) Statistical403 (PDF -359KB) PREA
Zoledronic acid - Zometa Novartis Pharmaceutical Corp. Medical404 (PDF -2MB) Clinical pharmacology405 (PDF -615KB) Statistical406 (PDF -422KB) BPCA
Zolmitriptan - Zomig AstraZeneca Medical407 (PDF -2MB) Clinical pharmacology408 (PDF -703KB) Statistical409 (PDF -368KB) PREA
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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)