| 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 -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)
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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