Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)
Act of 2012 (PREA)), as amended by FDASIA (Public Law 112-144), 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 = 26
Total Number of Products Studied under PREA = 96
Total Number of Products Studied under Both = 4
Total Number of Products Studied under PREA = 96
Total Number of Products Studied under Both = 4
| Drug | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Abacavir and Lamivudine - Epzicom | ViiV Healthcare Company | Medical (PDF -2.8MB) | Clinical pharmacology (PDF -158KB) | Statistical(PDF -693KB) | PREA |
| Abacavir sulfate - Ziagen | ViiV Healthcare Company | Medical (PDF -4.2MB) | Clinical pharmacology (PDF -3MB) | Statistical(PDF -4.7MB) | PREA |
| Acyclovir 5%, hydrocortisone 1% - Xerese | Valeant International Bermuda | Medical (PDF -885KB) | None | None | PREA |
| Adapalene and benzoyl peroxide - Epiduo | Galderma Laboratories, LP | Medical (PDF -2.2MB) | Clinical pharmacology (PDF -124KB) | Statistical(PDF -577KB) | PREA |
| Adapalene and benzoyl peroxide - Epiduo Forte | Galderma Research and Development LLC | Medical (PDF -6.2MB) | Clinical pharmacology (PDF -3.6MB) | Statistical(PDF -1.6MB) | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Pharmaceutical Products R. & D., Inc. | Medical (PDF -3MB) | Clinical pharmacologyf(PDF -4MB) | Statistical(PDF -2.2MB) | PREA |
Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT  | Neos Therapeutics, Inc. | Medical (PDF -470KB) | Clinical pharmacology (PDF -3.3MB) | None | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma | Medical (PDF -1.8MB) | Clinical pharmacology (PDF -4.8MB) | Statistical(PDF -767KB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF -5.7MB) Medical Addendum(PDF -1.1MB) Medical DD memo (PDF -2.9MB) | Clinical pharmacology (PDF -5MB) Clinical pharmacology addendum (PDF -424KB) | Statistical(PDF -1.4MB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF -553KB) | Clinical pharmacology (PDF -5MB) Addendum (PDF -105KB) | Statistical(PDF -1.2MB) | PREA |
| Aripiprazole - Abilify | Otsuka | Medical (PDF -2.4MB) | None | Statistical(PDF -409KB) | PREA |
| Asenapine - Saphris | Forest Laboratories, Inc. | Medical (PDF -5.4MB) Medical (PDF -4MB) | Clinical pharmacology (PDF -3.8MB) | Statistical(PDF -3MB) | BPCA |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF -14.1MB) | Clinical pharmacology (PDF -1MB) | Statistical(PDF -1.9MB) | BOTH |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF -1.6MB) | Clinical pharmacology (PDF -1MB) | Statistical(PDF -3.9MB) | BOTH |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals | Clinical (PDF -1.4MB) | None | Statistical(PDF -473 KB | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals Inc. | Medical (PDF -2MB) | None | None | PREA |
| Azelastine hydrochloride and Fluticasone propionate - Dymista | Meda Pharmaceuticals, Inc. | Medical (PDF -2.9MB) | None | Statistical(PDF -2.1MB) | BPCA |
| Barium sulfate - E-Z-HD | Bracco Diagnostics Inc. | Medical (PDF -2.4MB) | Clinical pharmacology (PDF -642KB) | Statistical(PDF -988KB) | PREA |
| Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE | Bracco Diagnostics | Medical (PDF -2.4MB) | Clinical pharmacology (PDF -702KB) | Statistical(PDF -1.2MB) | PREA |
| Beclomethasone dipropionate - Qnasl | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF -3.7MB) | Clinical pharmacology (PDF -1.5MB) | Statistical(PDF -959KB) | PREA |
| Bimatoprost ophthalmic solution, 0.03% – Latisse | Allergan, Inc. | DD Summary Review (PDF -966KB) CDTL Review (PDF -3.4MB) Medical (PDF -1.6MB) | None | Statistical(PDF -946KB) Statistical Addendum(PDF - 127KB) | PREA |
| Bortezomib - Velcade | Millennium Pharmaceuticals, Inc. | Medical (PDF -3.5MB) | Clinical pharmacology (PDF -1.2MB) | Statistical(PDF -374KB) | BPCA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF -5.6MB) | Clinical pharmacology (PDF -2.4MB) | Statistical(PDF -564KB) | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S c/o LEO Pharma, Inc. | Medical (PDF -3.7MB) | Clinical pharmacology (PDF -2.7MB) | None | PREA |
| Capecitabine - Xeloda | Hoffmann-La Roche, Inc. | Medical (PDF -4MB) | Clinical pharmacology (PDF -1MB) | Statistical(PDF -610KB) | BPCA |
| Carbinoxamine maleate - Karbinal ER | Tris Pharma, Inc. | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -500KB) | None | PREA |
| Ciclesonide - Zetonna | Takeda GmbH | Medical (PDF -5MB) | Clinical pharmacology (PDF -1.3MB) | Statistical(PDF -674KB) | PREA |
| 6% Ciprofloxacin Otic Suspension - Otiprio | Otonomy, Inc. | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -97KB) | Statistical(PDF -896KB) Addendum(PDF -157KB | PREA |
| Clonidine - Kapvay | Concordia Pharms Inc. | Medical (PDF -2.6MB) | None | Statistical(PDF -2MB) | PREA |
| Cysteamine bitartrate - Procysbi | Raptor Pharmaceuticals, Inc. | Medical (PDF -12MB) | Clinical pharmacology (PDF -1.3MB) Clinical pharmacology addendum (PDF -420KB) | None | BPCA |
| Darbepoetin alfa - Aranesp | Amgen Inc. | Medical (PDF -1.6MB) | None | Statistical(PDF -280KB) | BPCA |
| Darunavir - Prezista | Janssen Products, L.P. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1MB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | None | Clinical pharmacology (PDF -352KB) | None | PREA |
| Decitabine - Dacogen | Eisai Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -1MB) | None | BPCA |
| Deferasirox - Exjade | Novartis Pharmaceuticals Corporation | Medical (PDF -9MB) | Clinical pharmacology (PDF -1.5MB) | Statistical(PDF -2MB) | PREA |
| Dexmedtomidine hydrochloride - Precedex | Hospira | Medical (PDF -5MB) | Clinical pharmacology (PDF -3.8MB) | Statistical(PDF -1MB) | BPCA |
| Difluprednate ophthalmic emulsion - Durezol | Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd | Medical (PDF -748KB) | Clinical pharmacology (PDF -40KB) | Statistical(PDF -479KB) | BPCA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF -7.8MB) | Clinical pharmacology (PDF -10.8MB) | Statistical(PDF -4MB) | PREA |
| Doxycycline hyclate delayed-release - Doryx | Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC | Medical (PDF -241KB) | Clinical pharmacology (PDF -89KB) | Statistical(PDF -131KB) | PREA |
| Duloxetine - Cymbalta | Eli Lilly and Company, Inc. | Medical (PDF -2.2MB) | Clinical pharmacology (PDF -197KB) | Statistical(PDF -2.8MB) | PREA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF -8MB) | Clinical pharmacology (PDF -959KB) | Statistical(PDF -665KB) | BPCA |
| Econazole nitrate - Ecoza | AmDerma Pharmaceuticals, LLC | Medical (PDF -2MB) | Clinical pharmacology (PDF -2.5MB) | Statistical(PDF -422KB) | PREA |
| Efavirenz - Sustiva | Bristol-Myers Squibb Company | Medical (PDF -1.9MB) | Clinical pharmacology (PDF -9.3MB) | None | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF -4MB) | Clinical pharmacology (PDF -2MB) | Statistical(PDF -1MB) | BPCA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF -13.4MB) | Clinical pharmacology (PDF -24.2MB) | Statistical(PDF -2.2MB) | PREA |
| Emtricitabine/Rilpivirine/Tenofovir isoproxil fumarate - Complera | Gilead Sciences, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -145KB) | None | PREA |
| Entecavir - Baraclude | Bristol-Myers Squibb Company | Medical (PDF -3.4MB) | Clinical pharmacology (PDF -3MB) | Statistical(PDF -660KB) | BPCA |
| Erlotinib - Tarceva | OSI Pharmaceuticals, LLC | Medical (PDF -6.2MB) | Clinical pharmacology (PDF -2.2MB) | None | BPCA |
| Escitalopram oxalate - Lexapro | Forest Laboratories, Inc. | Medical (PDF -218KB) | None | None | BPCA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -883KB) | None | BPCA |
| Etravirine - Intelence | Janssen Products, L.P. | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -1.7MB) | None | PREA |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical (PDF -10MB) | Clinical pharmacology (PDF -2MB) | Statistical(PDF -315KB) | BPCA |
| Finafloxacin otic suspension - Xtoro | Alcon Research, Ltd. | Medical (PDF -6.8MB) | Clinical pharmacology (PDF -2MB) | Statistical(PDF -3.2MB) | BPCA |
| Fluticasone furoate inhalation powder - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF -8.6MB) | Clinical pharmacology (PDF -5.7MB) | Statistical(PDF -1.9) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -3MB) | Clinical pharmacology (PDF -1MB) | Statistical(PDF -317MB) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.4MB) | None | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical (PDF -1 MB) | Clinical pharmacology (PDF -267KB) | Statistical(PDF -52KB) | PREA |
| Gadobutrol - Gadavist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF -958KB) | Clinical pharmacology (PDF -2.2MB) | Statistical(PDF -422KB) | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF -3MB) | Clinical pharmacology (PDF -768KB) | Statistical(PDF -1.2MB) | PREA |
| Gadoxetate disodium - Eovist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.5MB) | None | PREA |
| Guanfacine - Intuniv | Shire | Medical (PDF -2.3MB) CTDL Review (PDF -2.56KB) | Clinical pharmacology (PDF -352KB) | Statistical(PDF -708KB) | Both |
| Guanfacine - Intuniv | Shire | Medical (PDF -3MB) | Clinical pharmacology (PDF -667KB) | Statistical(PDF -3MB) | PREA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | DD Summary Review (PDF -669KB) Medical (PDF -3MB) | Clinical pharmacology (PDF -3.7MB) | Statistical(PDF -378KB) | PREA |
| Iohexol - Oraltag | Interpharma Praha, a.s. | Medical (PDF -91KB) | Clinical pharmacology (PDF -294KB) | Statistical(PDF -98KB) | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -114KB) | Statistical(PDF -376KB) | PREA |
| Lamivudine - Epivir | ViiV Healthcare Company | Medical (PDF -4.2MB) | Clinical pharmacology (PDF -3MB) | Statistical(PDF -4.7MB) | PREA |
| Lamivudine and Raltegravir - Dutrebis | Merck Sharp & Dohme Corp. | Medical (PDF -1MB) | Clinical pharmacology (PDF -6.4MB) | None | PREA |
| Lamotrigine - Lamictal | GlaxoSmithKline LLC | Medical (PDF -18MB) | Clinical pharmacology (PDF -793KB) | Statistical(PDF -1.8MB) | PREA |
| Levalbuterol hydrochloride - Xopenex | Oak Pharmaceuticals | Medical (PDF -8.3MB) | Clinical pharmacology (PDF -3.9MB) | Statistical(PDF -2MB) | PREA |
| Levalbuterol tartrate - Xopenex HFA | Sunovion Pharmaceuticals Inc. | Medical (PDF -3.9MB) | Clinical pharmacology (PDF -1.2MB) | Statistical(PDF 1.3MB) | PREA |
| Levetiracetam - Keppra Extended Release Tablets | UCB, Inc. | DD Summary Review (PDF -202KB) CDTL Review (PDF -371KB) Medical (PDF -327KB) | Clinical pharmacology (PDF -1.2MB) | None | PREA |
| Levonorgestrel - Liletta | Medicines360 | Medical (PDF -8.8MB) | Clinical pharmacology (PDF -1MB) Clinical pharmacology (PDF -2.4MB) | Statistical(PDF -1.5MB) | PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF -6MB) | Clinical pharmacology (PDF -4MB) ) Clinical pharmacology addendum (PDF - 89KB) | Statistical(PDF -1MB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 8MB) | Clinical pharmacology (PDF - 4MB) | Statistical(PDF - 424KB) | PREA |
| Lisdexamfetamine mesylate - Vyvanse | Shire | Medical (PDF - 2.4MB) | None | Statistical(PDF - 1MB) | PREA |
| Lopinavir / Ritonavir - Kaletra | AbbVie Inc. | Medical (PDF -5.8MB) | Clinical pharmacology (PDF -2.3MB) | Statistical(PDF -1.9MB) | PREA |
| Memantine hydrochloride - XR Capsules | Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) | Medical (PDF -2.1MB) | Clinical pharmacology (PDF -956KB) | Statistical(PDF -1.1MB) | BPCA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF -8MB) | Clinical pharmacology (PDF -6MB) Clinical pharmacology addendum (PDF -425KB) | Statistical(PDF -1.4MB) | PREA |
| Mesalamine - Asacol HD | Warner Chilcott | Medical (PDF -6MB) | Clinical pharmacology (PDF -3.2MB) Clinical pharmacology (PDF - 518KB) | Statistical(PDF -499KB) | PREA |
| Mesalamine - Delzicol | Warner Chilcott LLC | Medical (PDF -2.8MB) Medical Addendum(PDF - 495KB) | Clinical pharmacology (PDF -116KB) | None | PREA |
| Mesalamine - Delzicol | Warner Chilcott (US), LLC | Medical (PDF -4.7MB) | Clinical pharmacology (PDF -729KB) | Statistical(PDF -1.1KB) | PREA |
| 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief | Hisamitsu Pharmaceutical Co., Inc. | Medical (PDF -998KB) Medical (PDF -3MB) | Clinical pharmacology (PDF -2.6MB) | Statistical(PDF -1.4MB) | PREA |
| Methylphenidate hydrochloride extended-release - Aptensio XR | Rhodes Pharmaceuticals L.P. | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -3.6MB) | Statistical(PDF -1.1MB) Statistical(PDF -629KB) | PREA |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical (PDF -26KB) | Clinical pharmacology (PDF -588KB) | Statistical(PDF -380KB) | PREA |
| Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER | Pfizer Inc. | CTDL Review (PDF -1.3MB) Medical (PDF -4.8MB) | Clinical pharmacology (PDF -2.9MB) | Statistical(PDF -498KB) | PREA |
| Micafungin sodium - Mycamine | Astellas Pharma US, Inc. | Medical (PDF -6.8MB) | Clinical pharmacology (PDF -1.8KB) | Statistical(PDF -987KB) | BPCA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohme Corp. | Medical (PDF -2.7MB) | Clinical pharmacology (PDF -1.5MB) | Statistical(PDF -603KB) | PREA |
| Naftifine hydrochloride - Naftin | Merz Pharmaceuticals, LLC | Medical (PDF -488KB) | Clinical pharmacology (PDF -1.6MB) | Statistical(PDF -188K) | PREA |
| Naloxone hydrochloride - Narcan Nasal Spray | Adapt Pharma Operations Limited | DD Summary Review(PDF -1.2MB) CTDL Review (PDF -3MB) | Clinical pharmacology (PDF -1.5MB) | None | PREA |
| Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM | Bayer HealthCare, LLC – Consumer Care | Medical (PDF -1MB) | Clinical pharmacology (PDF -1.7MB) | Statistical(PDF -1.3MB) | PREA |
| Neostigmine methylsulfate - Bloxiverz | Eclat Pharmaceuticals, LLC | Medical (PDF -7.7MB) | Clinical pharmacology (PDF -2MB) | None | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -446KB) | Statistical(PDF -723KB) | PREA |
| Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Minastrin 24 Fe | Warner Chilcott Company, LLC | Medical (PDF -1MB) | Clinical pharmacology (PDF -3.2MB) | Statistical(PDF -469KB) | PREA |
| Olanzapine and fluoxetine hydrochloride - Symbyax | Eli Lilly and Company | Medical (PDF -1.3MB) | Clinical pharmacology (PDF -1.2MB) Addendum (PDF - 132KB) | Statistical(PDF -953KB) | PREA |
| Olopatadine - Pazeo | Alcon Research LTD | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -340KB) | Statistical(PDF -4.3KB) | BPCA |
| Omalizumab - Xolair | Genentech | Medical (PDF -6MB) | Clinical pharmacology (PDF -1.3MB) | Statistical(PDF -2MB) | PREA |
| Omeprazole magnesium - Prilosec | AstraZeneca Pharmaceuticals LP | Medical (PDF -908KB) | Clinical pharmacology (PDF -1.6MB) | None | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical (PDF -5MB) | Clinical pharmacology (PDF -7MB) | Statistical(PDF -482KB) | PREA |
| Oxycodone hydrochloride - Oxycontin | Purdue Pharma L.P. | Medical (PDF -17.6MB) | Clinical pharmacology (PDF -2MB) | Statistical(PDF -678KB) | BPCA |
| Palifermin - Kepivance | Quintiles, Inc. | Medical (PDF -280KB) | Clinical pharmacology (PDF -726KB) | None | PREA |
| Palonosetron hydrochloride - Aloxi | Helsinn Healthcare SA | Medical (PDF -15MB) Medical (PDF -2MB) | Clinical pharmacology (PDF -2.3MB) | Statistical(PDF -771KB) | BPCA |
| Pancrelipase - Creon | AbbVie Inc. | Medical (PDF -566KB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical (PDF -587KB) | None | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF -4.8MB) | Clinical pharmacology (PDF -6MB) | Statistical(PDF -1.2MB) | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF -2.9MB) Medical (PDF -1.6MB) | Clinical pharmacology (PDF -4MB) | Statistical(PDF -1.3MB) | PREA |
| Phenylephrine hydrochloride ophthalmic solution | Paragon BioTeck, Inc | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -95KB) | Statistical(PDF -1MB) | PREA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. | Medical (PDF -3MB) | Clinical pharmacology (PDF -1.2MB) | Statistical(PDF -252KB) | PREA |
| Quetiapine fumarate - Seroquel and Seroquel XR | AstraZeneca Pharmaceuticals LP | CTDL Review (PDF -1MB) Medical (PDF -3.4MB) | Clinical pharmacology(PDF -1.8MB) Clinical pharmacology (PDF -739KB) | Statistical(PDF -785KB) | PREA |
| Rabeprazole sodium - AcipHex Sprinkle | Eisa Inc. | Medical (PDF - 3MB) | Clinical pharmacology (PDF - 5MB) | Statistical(PDF 185KB) | BPCA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF -1MB) | Clinical pharmacology (PDF -2.4MB) | None | PREA |
| Rifapentin - Priftin | Sanofi US Services Inc. | Medical (PDF -10.1MB) | Clinical pharmacology (PDF -5.1MB) | Statistical(PDF -3.1MB) | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -138KB) | None | PREA |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review (PDF -20KB) CTDL Review (PDF -1MB) Medical (PDF -670KB) Medical (PDF -667KB) | None | Statistical(PDF -237KB) | PREA |
| Rufinamide - Banzel | Eisai Inc. | Medical (PDF -9.4MB) | Clinical pharmacology (PDF -3MB) | None | BPCA |
| Sapropterin dihydrochloride - Kuvan | BioMarin Pharmaceutical Inc. | Medical (PDF -3.6MB) | Clinical pharmacology (PDF -2.5MB) | None | BPCA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Incorporated c/o Genentech, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1.5MB) | Statistical(PDF -1MB) | PREA |
| Selegiline - Emsam | Somerset Pharmaceuticals | Medical (PDF -1.1MB) Medical 2(PDF -1.2MB) Medical Secondary 1(PDF -349KB) Medical Secondary 2(PDF -188KB) | None | None | PREA |
| Sildenafil - Revatio | Pfizer, Inc. | Medical (PDF -6MB) | Clinical pharmacology (PDF -2MB) | Statistical(PDF -508KB) | BOTH |
| Spinosad - Natroba | ParaPRO, LLC | Medical (PDF -854KB) | Clinical pharmacology (PDF -171KB) | None | PREA |
| Sumatriptan/Naproxen - Treximet | Pernix Therapeutics | Medical (PDF -1.8MB) | Clinical pharmacology (PDF -2.8MB) | Statistical(PDF -843KB) Statistical Addendum(PDF -702KB) | BPCA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | Medical (PDF -2.4MB) | Clinical pharmacology (PDF -1.4MB) | Statistical(PDF -1.4MB) | PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -11.9MB) Medical Addendum(PDF - 418KB | Clinical pharmacology (PDF -5.9MB) | Statistical(PDF -1.3MB) Statistical Addendum(PDF -327KB) | PREA |
| Tobramycin 300 mg/4mL inhalation solution - Bethkis | Cornerstone Therapeutics | Medical (PDF -5.4MB) | Clinical pharmacology (PDF -78KB) | Statistical(PDF -687KB | PREA |
| Topiramate - Topamax | Janssen Pharmaceuticals, Inc. | Medical (PDF -8.6MB) | None | Statistical(PDF -881KB) | PREA |
| Tranexamic acid - Lysteda | Ferring Pharmaceuticals, Inc. | None | Clinical pharmacology (PDF -1.2MB) | None | PREA |
| Valganciclovir hydrochloride - Valcyte | Roche Palo Alto LLC c/o Genentech, Incorporated | Medical (PDF -2.7MB) | Clinical pharmacology (PDF -6MB) | None | PREA |
| Vigabatrin - Sabril | Lundbeck LLC. | Medical (PDF -4MB) | Clinical pharmacology (PDF -2.3MB) | Statistical(PDF -698KB) | BOTH |
| Zolmitriptan - Zomig | AstraZeneca Pharmaceuticals LP | Medical (PDF -4.5MB) | None | Statistical(PDF -2.9MB) | PREA |
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