Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012
As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, & Cosmetic Act (BPCA and PREA, respectively), 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.
Find the Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies in the FDA Archive
Total Number of Products Studied under BPCA = 28
Total Number of Products Assessed under PREA = 105
Total Number of Products Studied or assessed under Both = 31
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 | 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 -352KB) |
Clinical pharmacology (PDF -100KB) 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) 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 |
* Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.