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 -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 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)
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 |