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 = 37   
Total Number of Products Studied under PREA = 155
Total Number of Products Studied under Both = 5 

DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Abacavir and Lamivudine - EpzicomViiV Healthcare CompanyMedical (PDF - 2.8 MB)Clinical pharmacology (PDF - 158 KB)Statistical (PDF - 693 KB)PREA
Abacavir sulfate - ZiagenViiV Healthcare CompanyMedical (PDF - 4.2 M B)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 4.7 MB)PREA
Abatacept - OrenciaBristol-Myers Squibb Company

Medical (PDF - 259 KB)

Medical Addendum (PDF - 469 KB)

Clinical pharmacology (PDF - 2.3 MB)

Clinical pharmacology (PDF - 269 KB)

AbobotulinumtoxinA - DysportIpsen Bipharm LimitedCDTL Review (PDF - 2 MB)

Medical (PDF - 3 MB)
NoneStatistical (PDF -2 MB)PREA
Acetaminophen - OfirmevMallInc.krodt, Inc.Medical (PDF - 1.3 MB)Clinical pharmacology (PDF - 5.4 MB)Statistical (PDF -378 KB)PREA
Acyclovir 5%, hydrocortisone 1% - XereseValeant International BermudaMedical (PDF -885 KB)NoneNonePREA
Adalimumab-atto - AmjevitaAmgen Inc.

CDTL Review (PDF - 4.3 MB)

Medical (PDF - 199K B)

Medical (PDF - 336KB)

DD Summary Review (PDF - 2.9 MB)

Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 416 KB)

Statistical  (PDF - 363 KB)

Statistical (PDF - 717 KB)
Adapalene and benzoyl peroxide - EpiduoGalderma Laboratories, LPMedical (PDF -2.2 MB)Clinical pharmacology (PDF -124 KB)Statistical (PDF -577 KB)PREA
Adapalene and benzoyl peroxide - Epiduo ForteGalderma Research and Development LLCMedical (PDF -6.2 MB)Clinical pharmacology (PDF -3.6 MB)Statistical (PDF -1.6 MB)PREA
Albuterol sulfate - ProAir RespiClickTeva Pharmaceutical Products R. & D., Inc.Medical (PDF -3 MB)Clinical pharmacology (PDF -4 MB)Statistical (PDF -2.2 MB)PREA
Albuterol sulfate - ProAir RespiClick Teva Branded Pharmaceutical Products R&D, Inc.Medical (PDF -859 KB)Clinical pharmacology (PDF -2.5 MB)Statistical (PDF -1.1 MB)PREA
Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT Neos Therapeutics, Inc.Medical (PDF -470 KB)Clinical pharmacology (PDF -3.3 MB)NonePREA
Amphetamine - Dyanavel XRTris PharmaMedical (PDF -1.8 MB)Clinical pharmacology (PDF -4.8 MB)Statistical (PDF -767 KB)PREA
Aprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF -5.7 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF -2.9 MB)
Clinical pharmacology (PDF -5  MB)

Clinical pharmacology addendum (PDF -424 KB)
Statistical (PDF -1.4 MB)PREA
Aprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF -553KB)Clinical pharmacology (PDF -5MB)

Addendum (PDF -105KB)
Statistical (PDF -1.2MB)PREA
Aripiprazole - AbilifyOtsukaMedical (PDF -2.4MB)NoneStatistical (PDF -409KB)PREA
Asenapine - SaphrisForest Laboratories, Inc.Medical (PDF -5.4MB)

Medical (PDF -4MB)
Clinical pharmacology (PDF -3.8MB)Statistical (PDF -3MB)BPCA
Atazanavir - ReyatazBristol-Myers Squibb CompanyMedical (PDF -14.1MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -1.9MB)BOTH
Atazanavir - Reyataz Bristol-Myers Squibb CompanyMedical (PDF -1.6MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -3.9MB)BOTH
Atropine Sulfate - Isopto Atropine 1%Alcon Research, Ltd.Medical (PDF - 663KB)Clinical pharmacology (PDF - 480KB)Statistical (PDF - 230KB)PREA
Atropine Sulfate Ophthalmic SolutionAkorn, Inc.Medical (PDF - 1.2 MB)Clinical pharmacology (PDF - 1MB)Statistical (PDF - 287KB)PREA
Azelastine hydrochloride - AsteproMeda PharmaceuticalsClinical (PDF -1.4MB)NoneStatistical (PDF -473 KBPREA
Azelastine hydrochloride - AsteproMeda Pharmaceuticals Inc.Medical (PDF -2MB)NoneNonePREA
Azelastine hydrochloride and Fluticasone propionate - DymistaMeda Pharmaceuticals, Inc.Medical (PDF -2.9MB)NoneStatistical (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 DiagnosticsMedical (PDF -2.4MB)Clinical pharmacology (PDF -702KB)Statistical (PDF -1.2MB)PREA
Barium sulfate  - Varibar PuddingBracco Diagnostics, Inc.Medical (PDF - 1MB)NoneNone PREA
Barium sulfate - Liquid E-Z-PaqueBracco Diagnostics, Inc.DD Summary Review (PDF - 233 KB)NoneNonePREA
Beclomethasone dipropionate - QnaslTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF -3.7MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -959KB)PREA
Bimatoprost ophthalmic solution, 0.03% - LatisseAllergan, Inc.DD Summary Review (PDF -966KB)

CDTL Review (PDF -3.4MB)

Medical (PDF -1.6MB)
NoneStatistical (PDF -946KB)

Statistical Addendum (PDF - 127KB)
Bortezomib - VelcadeMillennium Pharmaceuticals, Inc.Medical (PDF -3.5MB)Clinical pharmacology (PDF -1.2MB)Statistical (PDF -374KB)BPCA
Budesonide - Entocort ECElan Pharma InternationalMedical (PDF -2.9MB)Clinical pharmacology (PDF -2.8MB)Statistical (PDF -920KBPREA
Budesonide/formoterol fumarate dehydrate -  SymbicortAstraZeneca Pharmaceuticals, LPMedical (PDF - 3.4 MB)Clinical pharmacology (PDF - 1.2 MB)Statistical (PDF - 2.5 MB)PREA
Cabazitaxel - Jevtana NEWSanofi-Aventis U.S., L.L.C.Medical (PDF - 1.5 MB)Clinical pharmacology (PDF - 1.2 MB)NoneBPCA
Calcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/SMedical (PDF -5.6MB)Clinical pharmacology (PDF -2.4MB)Statistical (PDF -564KB)PREA
Calcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/S c/o LEO Pharma, Inc.Medical (PDF -3.7MB)Clinical pharmacology (PDF -2.7MB)NonePREA
Capecitabine - XelodaHoffmann-La Roche, Inc.Medical (PDF -4MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -610KB)BPCA
Carbinoxamine maleate - Karbinal ERTris Pharma, Inc.Medical (PDF -1.4MB)Clinical pharmacology (PDF -500KB)NonePREA
Ceftaroline fosamil - Teflaro Cerexa, Inc., A Subsidiary of Forest Laboratories, LLCMedical (PDF -10.9MB)

Medical CTDL (PDF -1.5MB)
Clinical pharmacology (PDF -3MB)Statistical (PDF -1.2MB)BPCA
Cetirizine ophthalmic solution - Zerviate NEWNicox Ophthalmics, Inc.

Medical Resubmission (PDF - 231 KB)

Medical (PDF - 4.9 MB)

Clinical pharmacology (PDF - 279 KB)Statistical (PDF - 580 KB)BOTH
Ciclesonide - ZetonnaTakeda GmbHMedical (PDF -5MB)Clinical pharmacology (PDF -1.3MB)Statistical (PDF -674KB)PREA
Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic SolutionLaboratorios SALVAT, S.A.Medical (PDF -4MB)Clinical pharmacology (PDF -632KB)Statistical (PDF -2MB)PREA
6% Ciprofloxacin Otic Suspension - OtiprioOtonomy, Inc.Medical (PDF -2.3MB)Clinical pharmacology (PDF -97KB)Statistical (PDF -896KB)

Addendum (PDF -157KB
Ciprofloxacin ophthalmic solution - CiloxanNovartis Pharmaceuticals CorporationMedical (PDF -110 KB)NoneNoneBPCA 
Clonidine - KapvayConcordia Pharms Inc.Medical (PDF -2.6MB)NoneStatistical (PDF -2MB)PREA
Crisaborole Ointment, 2% -  EucrisaAnacor Pharmaceuticals Inc.CDTL Review (PDF - 2MB)

Medical (PDF - 12MB)
Clinical pharmacology (PDF - 7MB)Statistical (PDF - 1MB)PREA
Cysteamine bitartrate - ProcysbiRaptor Pharmaceuticals, Inc.Medical (PDF -12MB)Clinical pharmacology (PDF -1.3MB)

Clinical pharmacology addendum (PDF -420KB)
Dapsone - AczoneAllergan, Inc.Medical (PDF - 3.5 MB)Clinical pharmacology (PDF -  2.6 MB)Statistical (PDF -1.3 MB)PREA
Daptomycin - CubicinCubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp.Medical (PDF - 505 KB)Clinical pharmacology (PDF - 1.8 MB)


Statistical (PDF -1.9 KB)

Statistical Addendum (PDF - 96 KB)

Darbepoetin alfa - AranespAmgen Inc.Medical (PDF -1.6MB)NoneStatistical (PDF -280KB)BPCA
Darunavir - PrezistaJanssen Products, L.P.Medical (PDF -1MB)Clinical pharmacology (PDF -1MB)NonePREA
Darunavir - PrezistaJanssen Products, L.P.NoneClinical pharmacology (PDF -352KB)NonePREA
Decitabine - Dacogen Eisai Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -1MB)NoneBPCA
Deferasirox - ExjadeNovartis Pharmaceuticals CorporationMedical (PDF -9MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -2MB)PREA
Dexlansoprazole - DexilantTakeda Pharmaceuticals USA Inc.CDTL Review (PDF-661KB)

Medical (PDF-5MB)
Clinical pharmacology (PDF-1MB)Statistical (PDF-50KB)PREA
Dexmedtomidine hydrochloride - PrecedexHospiraMedical (PDF -5MB)Clinical pharmacology (PDF -3.8MB)Statistical (PDF -1MB)BPCA
Difluprednate ophthalmic emulsion - DurezolAlcon Pharmaceuticals Ltd. c/o Alcon Research LtdMedical (PDF -748KB)Clinical pharmacology (PDF -40KB)Statistical (PDF -479KB)BPCA
Dolutegravir - TivicayViiV HealthcareMedical (PDF -7.8MB)Clinical pharmacology (PDF -10.8MB)Statistical (PDF -4MB)PREA
Dolutegravir - Tivicay ViiV HealthcareMedical (PDF -1.6MB)

CDTL Review (PDF -932KB)
Clinical pharmacology (PDF -2.2MB)NonePREA
Doxycycline hyclate delayed-release - DoryxMayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLCMedical (PDF -241KB)Clinical pharmacology (PDF -89KB)Statistical (PDF -131KB)PREA
Duloxetine - CymbaltaEli Lilly and Company, Inc.Medical (PDF -2.2MB)Clinical pharmacology (PDF -197KB)Statistical (PDF -2.8MB)PREA
Duloxetine hydrochloride - CymbaltaEli Lilly and CompanyMedical (PDF -8MB)Clinical pharmacology (PDF -959KB)Statistical (PDF -665KB)BPCA
Econazole nitrate - EcozaAmDerma Pharmaceuticals, LLCMedical (PDF -2MB)Clinical pharmacology (PDF -2.5MB)Statistical (PDF -422KB)PREA
Efavirenz - SustivaBristol-Myers Squibb CompanyMedical (PDF -1.9MB)Clinical pharmacology (PDF -9.3MB)NoneBPCA
Eltrombopag - Promacta Novartis Pharmaceuticals CorporationMedical (PDF -3.5MB)Clinical pharmacology (PDF -1.2MB)Statistical (PDF -1MB)BPCA
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - GenvoyaGilead Sciences, Inc.Medical (PDF -13.4MB)Clinical pharmacology (PDF -24.2MB)Statistical (PDF -2.2MB)PREA
Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - StribildGilead Sciences, Inc.CTDL Review (PDF -359KB)Clinical pharmacology (PDF - 462KB)NonePREA
Emtricitabine, Rilpivirine, and Tenofovir alafenamide - OdefseyGilead Sciences, Inc.Medical (PDF -310KB)

CTDL Review (PDF -578KB)
Clinical pharmacology (PDF -5MB)

Clinical pharmacology addendum (PDF -297KB)
Emtricitabine, Rilpivirine, and Tenofovir alafenamide - DescovyGilead Sciences, Inc.Medical (PDF -1.27MB)

Addendum (PDF -572KB)
Clinical pharmacology (PDF -7.6MB)Statistical (PDF -1.9MB)PREA
Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - CompleraGilead Sciences, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -145KB)NonePREA
Emtricitabine and Tenofovir disoproxil fumarate - Truvada Gilead Sciences, Inc.Medical (PDF -501KB)Clinical pharmacology (PDF -189KB)NonePREA
Entecavir - BaracludeBristol-Myers Squibb CompanyMedical (PDF -3.4MB)Clinical pharmacology (PDF -3MB)Statistical (PDF -660KB)BPCA
Erlotinib - TarcevaOSI Pharmaceuticals, LLCMedical (PDF -6.2MB)Clinical pharmacology (PDF -2.2MB)NoneBPCA
Escitalopram oxalate - LexaproForest Laboratories, Inc.Medical (PDF -218KB)NoneNoneBPCA
Eszopiclone - LunestaSunovion Pharmaceuticals, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -883KB)NoneBPCA
Etanercept - EnbrelImmunex  Corporation, a wholly-owned subsidiary of Amgen Inc.

Medical (PDF - 4.8 MB)

DD Review (PDF - 568 KB)

CDTL Review PDF - 504 KB)

Clinical pharmacology  (PDF - 702 KB)Statistical (PDF - 444 KB)PREA
Etanercept-szzs - Erelzi NEWSandoz Inc.Medical (PDF - 1.7 MB)Clinical pharmacology (PDF - 4.7 MB)Statistical (PDF - 432 KB)PREA
Etravirine - IntelenceJanssen Products, L.P.Medical (PDF -1.4MB)Clinical pharmacology (PDF -1.7MB)NonePREA
Everolimus tablets for oral suspension - Afinitor DisperzNovartis Pharmaceuticals CorporationMedical (PDF -10MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -315KB)BPCA
Filgrastim-sndz - ZarxioSandoz, Inc.Medical (PDF -3.8MB)

DD Review  (PDF -86KB)

TL Review (PDF -422KB)
Clinical pharmacology (PDF -2.75MB)

Addendum (PDF - 1.1MB)
Statistical (PDF -6742KB)PREA
Finafloxacin otic suspension - XtoroAlcon Research, Ltd.Medical (PDF -6.8MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -3.2MB)BPCA
Fluticasone furoate inhalation powder - Arnuity ElliptaGlaxoSmithKlineMedical (PDF -8.6MB)Clinical pharmacology (PDF -5.7MB)Statistical (PDF -1.9)PREA
Fluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical (PDF -3MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -317MB)PREA
Fluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical (PDF -1.2MB)Clinical pharmacology (PDF -1.4MB)NonePREA
Fluticasone propionate/salmeterol xinafoate - Advair HFAGlaxoSmithKlineMedical (PDF -1 MB)Clinical pharmacology (PDF -267KB)Statistical (PDF -52KB)PREA
Fluticasone propionate - ArmonAir RespiClickTeva Pharmaceutical Industries Ltd.Medical (PDF -10 MB)Clinical pharmacology (PDF - 4.3MB)Statistical (PDF -1.2 KB)PREA
Fluticasone propionate/salmeterol - AirDuoTeva Pharmaceutical Industries Ltd.Medical (PDF -10 MB)Clinical pharmacology (PDF - 4.3 MB)Statistical (PDF -1.2 KB)PREA
Fosphenytoin sodium - CerebyxParke-Davis, a Division of Pfizer, Inc.CDTL Review (PDF - 390 KB)

Medical (PDF - 1.5 MB)
Clinical pharmacology (PDF - 5 MB)NonePREA
Gadobutrol - GadavistBayer HealthCare Pharmaceuticals, Inc.Medical (PDF -958KB)Clinical pharmacology (PDF -2.2MB)Statistical (PDF -422KB)PREA
Gadobutrol - GadavistBayer Healthcare Pharmaceuticals, Inc.Medical (PDF -7MB)NoneStatistical (PDF -782KB)PREA
Gadoterate meglumine - DotaremGuerbet LLCMedical (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)NonePREA
Gatifloxacin ophthalmic solution - ZymarAllergan, Inc.Medical (PDF - 78 KB)NoneNoneBPCA
Guanfacine - IntunivShireMedical (PDF -2.3MB)

CTDL Review (PDF -2.56KB)
Clinical pharmacology (PDF -352KB)Statistical (PDF -708KB)Both
Guanfacine - IntunivShireMedical (PDF -3MB)Clinical pharmacology (PDF -667KB)Statistical (PDF -3MB)PREA
Ibuprofen - CaldolorCumberland Pharmaceuticals, Inc.DD Summary Review (PDF -669KB)

Medical (PDF -3MB)
Clinical pharmacology (PDF -3.7MB)Statistical (PDF -378KB)PREA
Infliximab-dyyb - InflectraCelltrion, Inc.Medical (PDF -5.3MB)

Addendum (PDF - 1MB)
NoneStatistical (PDF -2MB)PREA
Infliximab-abda - RenflexisSamsung Bioepsis Co., Ltd

CDTL Review (PDF - 1 MB)

Medical (PDF - 3.5 MB)

Medical 2(PDF - 267 KB)

Medical 3 (PDF - 93 KB)

Clinical pharmacology (PDF - 7.7 MB)

Statistical (PDF - 959 KB)

Statistical 2 (PDF - 602 KB)

Insulin Degludec - TresibaNovo Nordisk Inc.CDTL Review (PDF -  7MB)

Medical (PDF - 7 MB)
Clinical pharmacology (PDF -  4MB)Statistical (PDF - 905KB)PREA
Insulin Degludec / Insulin Aspart) - RyzodegNovo Nordisk Inc.Medical (PDF - 7 MB)Clinical pharmacology (PDF -  4 MB)Statistical (PDF - 905 KB)PREA
Iohexol - OraltagInterpharma Praha, a.s.Medical (PDF -91 KB)Clinical pharmacology (PDF - 294 KB)Statistical (PDF - 98 KB)PREA
Iron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical (PDF -2 MB)Clinical pharmacology (PDF - 114 KB)Statistical (PDF -3 76KB)PREA
Lamivudine - EpivirViiV Healthcare CompanyMedical (PDF -4.2 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 4.7 MB)PREA
Lamivudine and Raltegravir - DutrebisMerck Sharp & Dohme Corp.Medical (PDF -1 MB)Clinical pharmacology (PDF - 6.4 MB)NonePREA
Lamotrigine - Lamictal GlaxoSmithKline LLCMedical (PDF -18 MB)Clinical pharmacology (PDF - 793 KB)Statistical (PDF - 1.8 MB)PREA
Ledipasvir-sofosbuvir - HarvoniGilead Sciences, Inc.Medical and CDTL (PDF - 1.5 MB)Clinical pharmacology (PDF - 539 KB)Statistical (PDF - 205 KB) 
Levalbuterol hydrochloride - XopenexOak PharmaceuticalsMedical (PDF -8.3 MB)Clinical pharmacology (PDF - 3.9 MB)Statistical (PDF - 2 MB)PREA
Levalbuterol tartrate - Xopenex HFASunovion Pharmaceuticals Inc.Medical (PDF -3.9 MB)Clinical pharmacology (PDF - 1.2 MB)Statistical (PDF 1.3 MB)PREA
Levetiracetam - Keppra Extended Release TabletsUCB, Inc.DD Summary Review (PDF - 202KB)

CDTL Review (PDF - 371 KB)

Medical (PDF - 327KB)
Clinical pharmacology (PDF - 1.2 MB)NonePREA
Levonorgestrel - LilettaMedicines360Medical (PDF - 8.8 MB)Clinical pharmacology (PDF - 1M B)

Clinical pharmacology (PDF - 2.4 MB)
Statistical (PDF - 1.5 MB)PREA
Levonorgestrel/ethinyl estradiol and ethinyl estradiol - QuartetteTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF -6MB)Clinical pharmacology (PDF - 4 MB)

Clinical pharmacology addendum (PDF - 89KB)
Statistical (PDF - 1MB)PREA
Levonorgestrel-releasing intrauterine system - SkylaBayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 8MB)Clinical pharmacology (PDF - 4MB)Statistical (PDF - 424 KB)PREA
Levothyroxine sodium oral solution - Tirosint-SOLCromsource, Inc.

CDTL Review (PDF - 461 KB)

Medical (PDF - 2.8 MB)

Clinical pharmacology (PDF - 1.8 MB)NonePREA
Llisdexamfetamine dimesylate - Vyvanse Shire Development, LLCMedical (PDF -  218 KB)Clinical pharmacology (PDF - 1 MB)NonePREA
Lisdexamfetamine mesylate - VyvanseShireMedical (PDF -  2.4 MB)NoneStatistical (PDF - 1 MB)PREA
Lopinavir / Ritonavir - KaletraAbbVie Inc.Medical (PDF - 5.8 MB)Clinical pharmacology (PDF -2.3 MB)Statistical (PDF - 1.9 MB)PREA
Lurasidone hydrochloride - LatudaSunovion Pharmaceuticals, Inc.Medical (PDF -  6 MB)
Medical (PDF -  6 MB)
Clinical pharmacology (PDF - 2 MB)Statistical (PDF -  368 KB)
Statistical (PDF - 254 KB)
Maraviroc - SelzentryViiv HealthcareMedical (PDF - 1.0 MB)Clinical pharmacology (PDF - 2.8 MB)NonePREA
Memantine hydrochloride - Namenda XRForest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.)Medical (PDF - 2.1 MB)Clinical pharmacology (PDF - 956 KB)Statistical (PDF - 1.1 MB)BPCA
Mepolizumab - NucalaGlaxoSmithKline LLCMedical (PDF - 8 MB)Clinical pharmacology (PDF - 6 MB)

Clinical pharmacology addendum (PDF -425KB)
Statistical (PDF - 1.4 MB)PREA
Mesalamine - Asacol HDWarner ChilcottMedical (PDF - 6MB)Clinical pharmacology (PDF - 3.2 MB)

Clinical pharmacology (PDF - 518 KB)
Statistical (PDF -499KB)PREA
Mesalamine  - CanasaForest LaboratoriesMedical (PDF - 6 MB)Clinical pharmacology (PDF - 251KB)Statistical (PDF - 344 KB)PREA
Mesalamine - DelzicolWarner Chilcott LLCMedical (PDF - 707 KB)

Medical Addendum(PDF - 495 KB)
Clinical pharmacology (PDF -116KB)NonePREA
Mesalamine - Delzicol Warner Chilcott (US), LLCMedical (PDF - 4.7 MB)Clinical pharmacology (PDF - 729 KB)Statistical (PDF - 1.1KB)PREA
10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief Hisamitsu Pharmaceutical Co., Inc.Medical (PDF - 998 KB)

Medical (PDF - 3 MB)
Clinical pharmacology (PDF - 2.6 MB)Statistical (PDF - 1.4 MB)PREA
Methylphenidate hydrochloride extended-release - Aptensio XRRhodes Pharmaceuticals L.P.Medical (PDF - 2.3 MB)Clinical pharmacology (PDF - 3.6M B)Statistical (PDF - 1.1 MB)
Statistical (PDF - 629 KB)
Methylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical (PDF - 26 KB)Clinical pharmacology (PDF - 588 KB)Statistical (PDF - 380 KB)PREA
Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER Pfizer Inc.CTDL Review (PDF -1.3MB)

Medical (PDF - 4.8 MB)
Clinical pharmacology (PDF -2.9MB)Statistical (PDF -498KB)PREA
Micafungin sodium - MycamineAstellas Pharma US, Inc.Medical (PDF - 6.8 MB)Clinical pharmacology (PDF -1.8KB)Statistical (PDF -987KB)BPCA
Mometasone furoate - Asmanex HFAMerck Sharp & Dohme Corp.Medical (PDF -2.7MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -603KB)PREA
Mometasone furoate - Asmanex HFAMerck Sharp & Dohm CorpMedical (PDF-1MB)NoneNonePREA
Mometasone furoate and formoterol fumarate - DuleraSchering-PloughMedical (PDF-1MB)NoneNonePREA

Moxifloxacin - Avelox

Bayer PharmaceuticalsMedical (PDF- 905KB)Clinical pharmacology (PDF -1.8MB)Statistical (PDF - 760KB)PREA
Moxifloxacin ophthalmic solution - Vigamox Alcon Pharmaceuticals, Ltd.Medical (PDF - 434 KB)

DD Summary Review (PDF- 118 KB)
Naftifine hydrochloride - NaftinMerz Pharmaceuticals, LLCMedical (PDF -488KB)Clinical pharmacology (PDF -1.6MB)Statistical (PDF - 188KB)PREA
Naftifine hydrochloride - Naftin Cream, 2%Merz Pharmaceuticals, LLCMedical (PDF - 1.2MB)Clinical pharmacology (PDF -1.6MB)Statistical (PDF - 822KB) PREA
Naloxone hydrochloride - Narcan Nasal SprayAdapt Pharma Operations LimitedDD Summary Review(PDF -1.2MB)

CTDL Review (PDF -3MB)
Clinical pharmacology (PDF -1.5MB)NonePREA
Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PMBayer HealthCare, LLC – Consumer CareMedical (PDF -1MB)Clinical pharmacology (PDF -1.7MB)Statistical (PDF -1.3MB)PREA
Neostigmine methylsulfate - BloxiverzEclat Pharmaceuticals, LLCMedical (PDF -7.7MB)Clinical pharmacology (PDF -2MB)NonePREA
Nevirapine - Viramune XRBoehringer 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 FeWarner Chilcott Company, LLCMedical (PDF -1MB)Clinical pharmacology (PDF -3.2MB)Statistical (PDF -469KB)PREA
Obiltoxaximab - AnthimElusys Theraputics, Inc.Medical (PDF -18MB)

Addendum (PDF -249KB)
Clinical pharmacology (PDF -12MB)

Addendum (PDF -126KB)
Statistical (PDF -9MB)PREA
Ocriplasmin- JetreaThromboGenics, Inc.Medical (PDF - 817KB)Clinical pharmacology (PDF - 117KB)Statistical (PDF - 760KB) PREA
Olanzapine and fluoxetine hydrochloride - SymbyaxEli Lilly and CompanyMedical (PDF -1.3MB)Clinical pharmacology (PDF -1.2MB)

Addendum (PDF - 132KB)

Statistical (PDF -953KB)PREA
Olopatadine - PazeoAlcon Research LTDMedical (PDF -2.3MB)Clinical pharmacology (PDF -340KB)Statistical (PDF -4.3KB)BPCA
Omalizumab - XolairGenentechMedical (PDF -6MB)Clinical pharmacology (PDF -1.3MB)Statistical (PDF -2MB)PREA
Omalizumab - XolairGenentech, Inc. and Novartis Pharmaceuticals Corp.Medical (PDF-4MB)Clinical pharmacology (PDF -1MB)Statistical (PDF-1MB) PREA
Omeprazole magnesium - Prilosec AstraZeneca Pharmaceuticals LPMedical (PDF -908KB)Clinical pharmacology (PDF -1.6MB)NonePREA
Oxcarbazepine - Oxtellar XRSupernus Pharmaceuticals, Inc.Medical (PDF -5MB)Clinical pharmacology (PDF -7MB)Statistical (PDF -482KB)PREA
Oxycodone hydrochloride - OxycontinPurdue Pharma L.P.Medical (PDF -17.6MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -678KB)BPCA
Palifermin - KepivanceQuintiles, Inc.Medical (PDF -280KB)Clinical pharmacology (PDF -726KB)NonePREA
Palonosetron hydrochloride - AloxiHelsinn Healthcare SAMedical (PDF -15MB)

Medical (PDF -2MB)
Clinical pharmacology (PDF -2.3MB)Statistical (PDF -771KB)BPCA
Pancrelipase - CreonAbbVie Inc.Medical (PDF -566KB)NoneNonePREA
Pancrelipase - Pancreaze Janssen Pharmaceuticals, Inc.Medical (PDF -142KB)NoneNonePREA
Pancrelipase - PertzyeDigestive Care, Inc.Medical (PDF - 1MB)NoneNonePREA
Pancrelipase - ZenpepAptalis Pharma Limited.Medical (PDF -587KB)NoneNonePREA
Paricalcitol - ZemplarAbbVie Inc.Medical (PDF - 3.0MB)

CDTL (PDF - 1.1MB)
Clinical pharmacology (PDF - 1.9MB)Statistical (PDF - 427KB)PREA
Perampanel - FycompaEisai, Inc.Medical (PDF -4.8MB)Clinical pharmacology (PDF -6MB)Statistical (PDF -1.2MB)PREA
Perampanel - FycompaEisai, Inc.Medical (PDF -2.9MB)
Medical (PDF -1.6MB)
Clinical pharmacology (PDF -4MB)Statistical (PDF -1.3MB)PREA
Perampanel - FycompaEisai Inc.Medical (PDF -2.6MB)

Medical  MTL (PDF -678KB)
Clinical pharmacology (PDF -1.2MB)NonePREA
Phentolamine mesylate - OraVerse Septodont Holding SasMedical (PDF -2.7MB)NoneStatistical (PDF -1.4MB)PREA
Phenylephrine hydrochloride ophthalmic solutionParagon BioTeck, Inc.Medical (PDF - 1MB)Clinical pharmacology (PDF - 95KB)Statistical (PDF -1MB)PREA
Posaconazole - NoxafilMerck Sharp & Dohme Corp.Medical (PDF - 3MB)Clinical pharmacology (PDF - 1.2MB)Statistical (PDF - 252KB)PREA
Posaconazole - NoxafilMerckMedical (PDF - 602KB)Clinical pharmacology (PDF -  645KB)NonePREA
Prasugrel - EffientEli Lilly and CompanyMedical (PDF - 2MB)Clinical pharmacology (PDF - 911KB)Statistical (PDF -290KB)BPCA
Pregabalin - LyricaPfizerMedical (PDF -  3.8MB)Clinical pharmacology (PDF - 5.9KB)Statistical (PDF - 825KB)PREA
Quetiapine fumarate - Seroquel and Seroquel XRAstraZeneca Pharmaceuticals LP

CTDL Review (PDF -1MB)

Medical (PDF - 3MB)

Clinical pharmacology(PDF -1.8MB)

Clinical pharmacology (PDF -739KB)

Statistical (PDF -785KB)PREA
Rabeprazole sodium - AcipHex SprinkleEisa Inc.Medical (PDF - 3MB)Clinical pharmacology (PDF - 5MB)Statistical (PDF 185KB)BPCA
Raltegravir - IsentressMerck Sharp Dohme CorpMedical (PDF -1MB)Clinical pharmacology  (PDF -2.4MB)NonePREA
Raltegravir - Isentress NEWMerck Sharp Dohme CorpCDTL Review (PDF - 4.5 MB)Clinical pharmacology  (PDF - 5 MB)Statistical (PDF 874 KB)PREA
Reslizumab - Cinqair  Teva Respiratory, LLCMedical (PDF -5MB)Clinical pharmacology (PDF -9MB)Statistical (PDF -1.6MB)PREA
Rifapentin - PriftinSanofi 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)NonePREA
Risperidone - Risperdal ConstaJanssen Pharmaceuticals, Inc.DD Summary Review (PDF -20KB)

CTDL Review (PDF -1MB)

Medical (PDF -670KB)

Medical (PDF -667KB)
NoneStatistical (PDF -237KB)PREA
Rufinamide - BanzelEisai Inc.Medical (PDF -9.4MB)Clinical pharmacology (PDF -3MB)NoneBPCA
Sapropterin dihydrochloride - KuvanBioMarin Pharmaceutical Inc.Medical (PDF -3.6MB)Clinical pharmacology (PDF -2.5MB)NoneBPCA
Saquinavir mesylate - InviraseHoffmann La-Roche, Inc.orporated c/o Genentech, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -1MB)PREA
Selegiline - EmsamSomerset PharmaceuticalsMedical (PDF -1.1MB)

Medical 2 (PDF -1.2MB)

Medical Secondary 1 (PDF -349KB)

Medical Secondary 2 (PDF -188KB)
Sevelamer Carbonate - RenvelaGenzyme/SanofiMedical (PDF - 745KB)Clinical pharmacology (PDF -  542KB)Statistical (PDF - 541KB)PREA
Sildenafil - RevatioPfizer, Inc.Medical (PDF - 6MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -508KB)BOTH
Spinosad - NatrobaParaPRO, LLCMedical (PDF - 854KB)Clinical pharmacology (PDF -171KB)NonePREA
Sofosbuvir - SovaldiGilead Sciences, Inc.Medical and CDTL (PDF - 345 KB)Clinical pharmacology (PDF - 511 KB)NonePREA
Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - LumasonBracco Diagnostics Inc.Medical (PDF - 5.1MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -792KB)PREA
Sulfur Hexafluoride Lipid-Type A Microspheres - LumasonBracco Diagnostics, Inc.Medical (PDF - 3MB)

CDTL (PDF - 1.1MB)
Clinical pharmacology (PDF - 1MB)Statistical (PDF - 859KB)PREA
Sumatriptan/Naproxen - TreximetPernix TherapeuticsMedical (PDF -1.8MB)Clinical pharmacology (PDF -2.8MB)Statistical (PDF -843KB)

Statistical Addendum (PDF -702KB)
Tenofovir disoproxil fumarate - VireadGilead SciencesMedical (PDF - 2.4MB)Clinical pharmacology (PDF - 1.4MB)Statistical (PDF - 1.4MB)PREA
Tetracaine hydrochloride - NoneAlcon Research, Ltd.DD Medical Summary  (PDF -1.8MB)

Medical (PDF -1.4MB)
Clinical pharmacology (PDF - 158KB)Statistical (PDF - 2.3MB)PREA
Tetracaine HCl and Oxymetazoline HCl - Kovanaze St. Renatus, LLCMedical (PDF - 11.8MB)Clinical pharmacology (PDF - 11.6MB)Statistical (PDF - 2.4MB)PREA
Tiotropium bromide - Spiriva RespimatBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF -11.9MB)

Medical Addendum (PDF - 418KB
Clinical pharmacology (PDF - 5.9MB)Statistical (PDF - 1.3MB)

Statistical Addendum (PDF -327KB)
Tiotropium bromide - Spiriva Respimat Boehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF -  4.8MB)Clinical pharmacology (PDF - 2MB)Statistical (PDF - 432KB)PREA
Tobramycin 300 mg/4mL inhalation solution - BethkisCornerstone TherapeuticsMedical (PDF - 5.4MB)Clinical pharmacology (PDF - 78KB)Statistical (PDF - 687KBPREA
Topiramate - TopamaxJanssen Pharmaceuticals, Inc.Medical (PDF - 8.6MB)NoneStatistical (PDF - 881KB)PREA
Tranexamic acid - LystedaFerring Pharmaceuticals, Inc.NoneClinical pharmacology (PDF - 1.2MB)NonePREA
Valganciclovir hydrochloride - ValcyteRoche Palo Alto LLC c/o Genentech, Inc.orporatedMedical (PDF -2 .7MB)Clinical pharmacology (PDF - 6MB)NonePREA
Vigabatrin - SabrilLundbeck LLC.Medical (PDF - 4MB)Clinical pharmacology (PDF - 2.3MB)Statistical (PDF - 698KB)BOTH
Zolmitriptan - Zomig AstraZeneca Pharmaceuticals LPMedical (PDF -4.5MB)NoneStatistical (PDF -2.9MB)PREA

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

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