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  1. Development & Approval Process (Drugs)

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2007-2012

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2007-2012

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 = 28
Total Number of Products Studied under PREA = 105
Total Number of Products Studied 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 -913KB) None PREA
Azelastine hydrochloride - Astepro MEDA Medical (PDF -633KB)
Medical (PDF -3MB)
Clinical pharmacology (PDF -540KB) Statistical (PDF -204KB)
Statistical (PDF -985KB)
PREA
Azelastine hydrochloride and Fluticasone proprionate - Dymista Meda Pharmaceuticals, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -2MB) PREA
Azithromycin - Zmax Pfizer Medical (PDF -76KB) Clinical pharmacology (PDF -67KB) None PREA
Balanced salt ophthalmic solution with hypromellose, dextrose and glutathione - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical (PDF -4 MB) Clinical pharmacology (PDF -49KB) None PREA
Beclomethasone dipropionate - QNASL Nasal Aerosol Teva Branded Pharmaceutical Products R&D, Inc Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) Statistical (PDF - 714 KB) PREA
Bendamustine hydrochloride - Treanda Teva Pharmaceuticals Medical (PDF -6MB) Clinical pharmacology (PDF -1MB) None BPCA
Benzyl Alcohol - Ulesfia Asphyxiator Sciele Pharma, Inc Medical (PDF -299KB) Clinical pharmacology (PDF -268KB) Statistical (PDF -932KB) PREA
Bepotastine besilate - Bepreve Ista Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -693KB) Statistical (PDF -696KB) PREA
Besifloxacin hydrochloride - Besivance Bausch & Lomb Medical (PDF -2MB)[*note for vision impaired users] Clinical pharmacology (PDF -684KB) Statistical (PDF -1MB)[*note for vision impaired users] PREA
Bicalutamide - Casodex AstraZeneca Pharmaceuticals Medical (PDF -1MB) Clinical pharmacology (PDF -579KB) Statistical (PDF -207KB) BPCA
Bivalirudin - Angiomax The Medicines Company Medical (PDF -717KB) Clinical pharmacology (PDF -2MB) None BPCA
Brimonidine tartrate - Timolol maleate - Combigan Allergen, Inc. Medical (PDF -2MB)[*note for vision impaired users] Clinical pharmacology (PDF -137KB)[*note for vision impaired users] Statistical (PDF -716KB)[*note for vision impaired users] PREA
Candesartan Cilexitil - Atacand Astra Zeneca Medical (PDF -1MB) Clinical pharmacology (PDF -991KB) Statistical (PDF -435KB) BPCA
Caspofungin acetate - Cancidas Merck Medical (PDF -3MB) Clinical pharmacology (PDF -465KB) Statistical (PDF -352KB) Both
Ciclesonide - Alvesco Aventis Medical (PDF -9MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -300KB) PREA
Ciclesonide - Omnaris NYCOMED Medical (PDF -2MB) Clinical pharmacology (PDF -165KB) Statistical (PDF -158KB) PREA
Ciprofloxacin otic solution - Cetraxal Parexel International Medical (PDF -282KB) Clinical pharmacology (PDF -245KB) Statistical (PDF -511KB) PREA
Clindamycin phosphate/Benzoyl peroxide -Acanya Gel Dow Pharmaceutical Sciences, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -487KB) Statistical (PDF -836KB) PREA
Clonidine hydrochloride - Kapvay Shinoga Medical (PDF 1MB) Clinical pharmacology (PDF -225KB) Statistical (PDF -532MB) PREA
Clopidogrel bisulfate - Plavix Sanofi Aventis U.S. LLC Medical (PDF -478MB)

Clinical pharmacology (PDF -568KB)

Biopharmaeutic review (PDF -551KB)

Statistical (PDF -72KB) BPCA
Colchicine - Colcrys United Research Laboratories, Inc./Mutual Pharmaceuticals Company Inc. Medical (PDF -51KB) Clinical pharmacology (PDF -51KB) None BPCA
Colesevelam hydrochloride - Welcho Daiichi-Sankyo Medical (PDF -8MB ) None Statistical (PDF -4MB) Both
Darunavir - Prezista Tibotec Medical (PDF -2MB) Clinical pharmacology (PDF - 949KB) None Both
Darunavir - Prezista Tibotec, Inc

Medical (PDF -1.8MB)

Medical (PDF -478KB)

Medical (PDF -286KB)

Clinical pharmacology (PDF -2.7MB)

Clinical pharmacology (PDF -793KB)

None BPCA
Desmopressin acetate Ferring Pharmaceuticals Inc. Medical (PDF -287KB) Clinical pharmacology (PDF -850KB ) None PREA
Dexmethylphenidate hydrochloride - Focalin XR Novartis Pharmaceuticals Corporation Medical (PDF -333KB) Clinical pharmacology (PDF -830KB) Statistical (PDF -151KB) PREA
Didanosine - Videx EC Bristol-Myers Squibb Company Medical (PDF -483KB) Clinical pharmacology (PDF -830KB) None PREA
Divalproex - Depakote ER and Depakote Sprinkle Abbott

Medical (PDF -100KB)
Medical (PDF -2MB)
Medical (PDF -1MB)

Medical (PDF -352KB)

Clinical pharmacology (PDF -100KB)

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 -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -336KB) Both
Esomeprazole sodium - Nexium I.V. AstraZeneca LP Medical (PDF -644KB) Clinical pharmacology (PDF -2MB) None PREA
Estradiol valerate and estradiol valerate/dienogest - Natazia Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF -1.9MB) Clinical pharmacology (PDF -494KB) Statistical (PDF -391KB) PREA
Etravirine - Intelence Janssen Products, L.P. Medical (PDF -945KB) Clinical pharmacology (PDF -2MB) None PREA
Everolimus - Afinitor Novartis Pharmaceuticals Corporation Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) None BPCA
Ezetimbe/simvastatin - Vytorin Merck Schering-Plough Singapore Co., LLC Medical (PDF -2MB) Clinical pharmacology (PDF -200KB) Statistical (PDF -179KB) Both
Ezetimbe - Zetia Merck Schering Plough Singapore Co., LLC Medical (PDF -336KB) Clinical pharmacology (PDF -86KB) Statistical (PDF -375KB) Both
Famciclovir - Famvir Novartis Pharmaceutical Corporation Medical (PDF -779KB) Clinical pharmacology (PDF -354KB) None Both
Fluocinolone acetonide - Derma-Smoothe/FS Hill Dermaceuticals, Inc Medical (PDF -943KB) Clinical pharmacology (PDF -276KB) Statistical (PDF -507KB) 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 -194KB)
Medical (PDF -538KB)
Clinical pharmacology (PDF -437KB) Statistical (PDF -774KB) PREA
Gadobenate dimeglumine - MultiHance Bracco Diagnostics Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -455KB) Statistical (PDF -545KB) PREA
Gadobutrol - Gadavist Bayer Healthcare Pharmaceuticals, Inc Medical (PDF -989KB) Clinical pharmacology (PDF -1MB) Statistical (PDF -375KB) PREA
Gatifloxacin - Zymar Allergan, Inc. Medical (PDF -573KB) Clinical pharmacology (PDF -60KB) Statistical (PDF -376KB) BPCA
Gatifloxacin - Zymaxid Allergan, Inc. Medical (PDF -3MB) Clinical pharmacology (PDF -119KB) Statistical (PDF -611KB) PREA
Granisetron hydrochloride - Kytril Hoffmann-La Roche Inc. Medical (PDF -409KB) Clinical pharmacology (PDF -17KB) Statistical (PDF -38KB) PREA
Guanfacine - Intuniv Shire Development, Inc. Medical (PDF -440KB) Clinical pharmacology (PDF -286KB) Statistical (PDF -493KB) PREA
Guanfacine hydrochloride - Intuniv Shire Development, Inc. Medical (PDF -465kb)
Medical (PDF -35KB)
Medical (PDF -118KB)
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 -676KB) 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 UCB, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -2MB) Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical (PDF -97KB) Clinical pharmacology (PDF -668KB) None Both
Levocetirizine dihydrochloride - Xyzal UCB, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -419KB) None Both
Levofloxacin - Levaquin Ortho McNeil Janssen Pharmaceuticals Inc Medical (PDF -239KB) Clinical pharmacology (PDF -828KB) Statistical (PDF -39KB) PREA
Levonorgestrel-releasing intrauterine system - Mirena Bayer HealthCare Pharmaceuticals Medical (PDF -1MB) Clinical pharmacology (PDF -358KB) Statistical (PDF -71KB) PREA
Levonorgestrel - Plan B one step Duramed Medical (PDF -116KB)
Medical (PDF -315KB)
Clinical pharmacology (PDF -47KB)
Clinical pharmacology (PDF -72KB)
Statistical (PDF -26KB) PREA
Lidocaine hydrochloride - Akten Akorn, Inc. Medical (PDF -120KB) Clinical pharmacology (PDF -57KB) Statistical (PDF -292KB) PREA
Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical (PDF -2MB) None (PDF) Statistical (PDF -676KB) PREA
Lisdexamfetamine dimesylate - Vyvanse Shire Development, Inc. Medical (PDF -688KB) None Statistical (PDF -792KB) PREA
Lopinavir/ritonavir - Kaletra Abbott Medical (PDF -3MB) Clinical pharmacology (PDF -904KB) None Both
Loteprednol etabonate 0.5% and tobramycin 0.3% - Zylet Bausch & Lomb Medical (PDF -37MB)
Medical (PDF -24KB)
None None PREA
Loteprednol etabonate and tobramycin ophthalmic suspension - Zylet Bausch & Lomb, Incorporated Medical (PDF -84KB) None None BOTH
Mannitol - Aridol Pharmaxis Ltd Medical (PDF - 396KB) Clinical pharmacology (PDF -226KB) Statistical (PDF -2MB) PREA
Methylphenidate hydrochloride - Quillivant NextWave Pharmaceuticals, Inc.

Medical (PDF -201KB)

Memo (PDF -320KB)

Clinical pharmacology (PDF -67KB)

Clinical pharmacology (PDF -225KB)

Statistical (PDF -241KB PREA
Methylphenidate Transdermal System - Daytrana Shire Pharmaceuticals Medical (PDF -2MB)
Medical (PDF -36KB)
Clinical pharmacology (PDF -568KB) Statistical (PDF -162KB) PREA
Mometasone furoate - Asmanex Twisthaler Schering Plough Corporation Medical (PDF -4MB) Clinical pharmacology (PDF -595KB) Statistical (PDF -548KB)
Statistical (PDF -250KB)
PREA
Mometasone furoate - Nasonex Schering-Plough Medical (PDF 155KB) None Statistical (PDF -627KB) PREA
Mometasone furoate monohydrate - Nasonex Schering-Plough Medical (PDF 435KB) Clinical pharmacology (PDF -143KB) Statistical (PDF -176KB) PREA
Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical (PDF -1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -433KB) PREA
Montelukast sodium - Singulair Merck Sharp & Dohme Corp. Medical (PDF -2MB) Clinical pharmacology (PDF -74KB) Statistical (PDF -94KB) PREA
Moxifloxacin hydrochloride ophthalmic solution 0.5% as base - Moxeza AF Alcon Research Ltd. Medical (PDF -615KB) Clinical pharmacology (PDF -235KB) Statistical (PDF -580KB) PREA
Nevirapine - Viramune Boehringer Ingelheim Medical (PDF -1MB) Clinical pharmacology (PDF -926KB) None PREA
Nitric Oxide - INOmax INO Therapeutics Medical (PDF -1MB) Clinical pharmacology (PDF -45KB) Statistical (PDF -612KB) BPCA
Norethindrone acetate and ethinyl estradiol, ethinyl estradiol, and ferrous fumarate - Lo Loestrin Fe Warner Chilcott Company, Inc. Medical (PDF -166KB) Clinical pharmacology (PDF -50KB) Statistical (PDF -31KB) PREA
Norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets - TBD Warner Chilcott, LLC Medical (PDF -505KB) Clinical pharmacology (PDF -21KB) Statistical (PDF -106KB) PREA
Olanzapine - Zyprexa Eli Lilly Medical (PDF -41KB)
Medical (PDF -40KB)
Medical (PDF -62KB)

Medical (PDF -2MB)
Medical (PDF -604KB)

BPCA Summary (PDF -76KB

Clinical pharmacology (PDF -962KB) Statistical (PDF -452KB)
Statistical Addendum (PDF -159KB)
Both
Olmesartan Medoxomil - Benicar Daiichi Sankyo Medical (PDF -2MB) Clinical pharmacology (PDF -964KB) Statistical (PDF -527KB) Both
Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical (PDF -3MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -3MB) PREA
Olopatadine hydrochloride - Patanase Alcon Research, Ltd. Medical (PDF -3.2MB) Clinical pharmacology (PDF -791KB) Statistical (PDF -315KB) Both
Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF -1MB) Clinical pharmacology (PDF -845KB) Statistical (PDF -703KB) PREA
Omeprazole magnesium - Prilosec AstraZeneca LLP Medical (PDF -318KB) Clinical pharmacology (PDF -869KB) None PREA
Paliperidone - Invega Ortho-McNeil-Janssen Pharmaceuticals, Inc. Medical (PDF -289MB) Clinical pharmacology (PDF -447KB) Statistical (PDF -252KB) BOTH
Pancrelipase - Creon  Abbott Products Inc. Medical (PDF -702KB) Clinical pharmacology (PDF -58KB) Statistical (PDF -84KB) PREA
Pancrelipase - Pancreaze Johnson & Johnson Pharmaceutical Research & Development, L.L.C Medical (PDF -2MB) Clinical pharmacology (PDF -546KB) Statistical (PDF -326KB) PREA
Pancrelipase - Pertyze Digestive Care, Inc. Medical (PDF -4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -736KB) PREA
Pancrelipase - Ultrase Axcan Scandipharm, Inc. Medical (PDF -4MB)
Safety (PDF -230KB)
Safety (PDF -119KB)

Clinical pharmacology (PDF -116KB)

Clinical pharmacology (PDF -1MB)

None PREA
Pancrelipase - Zenpep Eurand Pharmaceuticals Ltd. Medical (PDF -2MB) Clinical pharmacology (PDF -502KB) Statistical (PDF -377KB) PREA
Pantoprazole sodium - Protonix Wyeth Pharmaceuticals, Inc. DD Summary Review (PDF -907KB)
CDTL Review (PDF -597KB)
Medical (PDF -11MB)
Medical Addendum (PDF -260KB)
Clinical pharmacology (PDF -8MB) Statistical (PDF -721KB) Both
Pegfilgrastim - Neulasta Amgen Medical (PDF -965KB) [*note for vision impaired users] Clinical pharmacology (PDF -945KB) [*note for vision impaired users] None PREA
Peginterferon - PegIntron Schering-Plough Research Institute Medical (PDF -937KB) Clinical pharmacology (PDF -825KB) Statistical (PDF -1MB) PREA
Pemetrexed disodium - Alimta Eli Lilly and Company Medical (PDF -632KB) Clinical pharmacology (PDF -207KB) Statistical (PDF -364KB) BPCA
Phentolamine - OraVerse Novalar Pharmaceuticals, Inc. Medical (PDF -4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -762KB) PREA
Pilocarpine hydrochloride - Isopto Carpine Alcon Research, Ltd. Medical (PDF -4MB) Clinical pharmacology (PDF -462KB) Statistical (PDF -1MB) PREA
Quetiapine fumarate - Seroquel Astra-Zeneca Medical (PDF -3MB)
Medical Addendum (PDF -700KB)
Clinical pharmacology (PDF -2MB) Statistical (PDF -776KB) Both
Rabeprazole sodium - Aciphex Eisai Medical Research Inc. Medical (PDF -611KB) Clinical pharmacology (PDF -682KB) None PREA
Raltegravir - Isentress Merck Sharp & Dohme Corp Medical (PDF -3MB) Clinical pharmacology (PDF -3MB) None PREA
Retapamulin - Altabax GlaxoSmithKline Medical (PDF -359KB) Clinical pharmacology (PDF -408KB) None PREA
Ribavirin / Peginterferon alfa-2a - Copegus / Pegasys Hoffmann-La Roche Inc Medical (PDF -1MB) Clinical pharmacology (PDF -69KB) Medical (PDF -1MB) PREA
Risedronate sodium - Actonel Procter & Gamble Pharmaceuticals, Inc Medical (PDF -437KB) Clinical pharmacology (PDF -636KB) Statistical (PDF -255KB) Both
Rizatriptan - Maxalt-MLT Merck Research Laboratories Medical (PDF -2.6MB)
Medical (PDF -659KB)
CTDL Review (PDF -221KB)
CTDL Addendum (PDF -112KB)
DD Memo (PDF -22KB)
Clinical pharmacology (PDF -2MB) Statistical (PDF -374KB)
Statistical (PDF -381KB)
BPCA
Rocuronium bromide - Zemuron Organon USA, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -877KB) None Both
Rosuvastatin - Crestor AstraZeneca Pharmaceuticals LP Medical (PDF -3MB) Clinical pharmacology (PDF -603KB) Statistical (PDF -482KB) Both
Saquinavir mesylate - Invirase Hoffmann-La Roche Inc. Medical (PDF -366 KB) Clinical pharmacology (PDF -706KB) Statistical (PDF -446KB) PREA
Somatropin - Accretropin Cangene Corporation Medical (PDF -3MB) Clinical pharmacology (PDF -7MB) Statistical (PDF -2MB) PREA
Spinosad - Natroba Suspension, 0.9% ParaPRO Medical (PDF -278KB) Clinical pharmacology (PDF -50KB) Statistical (PDF -46KB)   Statistical (PDF -23KB)    PREA
Sterile Intraocular - Navstel Intraocular Irrigating Solution Alcon, Inc. Medical (PDF -8MB) Clinical pharmacology (PDF -85KB) None PREA
Tamsulosin hydrochloride - Flomax Boehringer Ingelheim Medical (PDF -3MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -253KB) BPCA
Technetium Tc99m - Cardiolite Bristol Myers Squibb Medical (PDF -561KB) Clinical pharmacology (PDF -571KB) Statistical (PDF -357KB) BPCA
Temsirolimus - Torisel  Wyeth Pharmaceuticals, a Pfizer Company Medical (PDF -2MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -250KB) BPCA
Tenofovir disoproxil fumarate - Viread Gilead Medical (PDF -3MB) Clinical pharmacology (PDF -474KB) Statistical (PDF -1MB) PREA
Tenofovir disoproxil fumarate - Viread Gilead Sciences, Incorporated Medical (PDF -647KB) Clinical pharmacology (PDF -1.66MB) Statistical (PDF -774KB) BPCA
Terbinafine - Lamisil Novartis Pharmaceuticals Corp. Medical (PDF -6MB)[*note for vision impaired users] Clinical pharmacology (PDF -3MB)[*note for vision impaired users] Statistical (PDF -2MB)[*note for vision impaired users] BPCA
Tipranavir - Aptivus Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -589KB) Both
Tocilizumab - Actemra Genentech, Inc. A Member of the Roche Group Medical (PDF -1.4MB) Clinical pharmacology (PDF 670KB) Statistical (PDF -543KB) PREA
Topiramate - Topamax Janssen Pharmaceuticals, Inc. Medical (PDF -7MB) Clinical pharmacology (PDF -1MB) None PREA
Topiramate - Topamax Johnson and Johnson Pharmaceutical
Research & Development L.L.C.
Medical (PDF -3MB) Clinical pharmacology (PDF -986KB) None BPCA
Triamcinolone acetonide - Triesence Alcon, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -802KB) Statistical (PDF -402KB) PREA
Triamcinolone acetonide - Nasacort AQ Sanofi Aventis Medical (PDF -882KB) Clinical pharmacology (PDF -810KB) Statistical (PDF -615KB) PREA
Ulipristal acetate - Ella Laboratoire HRA Pharma Medical (PDF -1MB) Clinical pharmacology (PDF -2MB)
Clinical pharmacology Addendum (PDF -46KB)
Statistical (PDF -3MB) PREA
Valacyclovir hydrochloride - Valtrex GlaxoSmithKline Medical (PDF -719KB) Clinical pharmacology (PDF -506KB)
Clinical pharmacology (PDF -646KB)
None Both
Valganciclovir hydrochloride - Valcyte Hoffmann-La Roche, Inc. Medical (PDF -1MB)
Medical (PDF -358KB)
Clinical pharmacology (PDF -179KB)
Clinical pharmacology (PDF -2MB)
None Both
Valsartan - Diovan Novartis Medical (PDF -1MB) Clinical pharmacology (PDF -10MB) Statistical (PDF -2MB) BPCA
Varenicline - Chantix Pfizer, Inc. None Clinical pharmacology (PDF -93KB) None PREA
Zidovudine, ZDV - Retrovir GlaxoSmithKline Medical (PDF -767KB) Clinical pharmacology (PDF -686KB) None PREA
Zidovudine - Retrovir ViiV Healthcare Co Medical (PDF -757KB) Clinical pharmacology (PDF -285) None PREA
Ziprasidone - Geodon Pfizer Medical (PDF -2MB)
Medical Addendum (PDF -63KB)
Clinical pharmacology (PDF -2MB) Statistical (PDF -359KB) PREA
Zoledronic acid - Zometa Novartis Pharmaceutical Corp. Medical (PDF -2MB) Clinical pharmacology (PDF -615KB) Statistical (PDF -422KB) BPCA
Zolmitriptan - Zomig AstraZeneca Medical (PDF -2MB) Clinical pharmacology (PDF -703KB) Statistical (PDF -368KB) PREA

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