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)

In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2012 (BPCA)) and section 505B(h)(1) of the Act (Pediatric Research Equity 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 = 22
Total Number of Products Studied under PREA = 77
Total Number of Products Studied under Both = 4


DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Abacavir sulfate - ZiagenViiV Healthcare CompanyMedical (PDF -4.2MB)Clinical pharmacology (PDF -3MB)Statistical (PDF -4.7MB)PREA
Acyclovir 5%, hydrocortisone 1% - XereseValeant International BermudaMedical (PDF -885KB)NoneNonePREA
Adapalene and benzoyl peroxide - EpiduoGalderma Laboratories, LPMedical (PDF -2.2MB)Clinical pharmacology (PDF -124KB)Statistical (PDF -577KB)PREA
Albuterol sulfate - ProAir RespiClick Teva Pharmaceutical Products R. & D., Inc.Medical (PDF -3MB)Clinical pharmacologyf(PDF -4MB)Statistical (PDF -2.2MB)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 - Reyataz Bristol-Myers Squibb CompanyMedical (PDF -14.1MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -1.9MB)BOTH
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
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)
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
Ciclesonide - ZetonnaTakeda GmbHMedical (PDF -5MB)Clinical pharmacology (PDF -1.3MB)Statistical (PDF -674KB)PREA
Clonidine - KapvayConcordia Pharms Inc.Medical (PDF -2/6MB)NoneStatistical (PDF -2MB)PREA
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
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
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 -4MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -1MB)BPCA
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
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
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
Gadobutrol - GadavistBayer HealthCare Pharmaceuticals, Inc.Medical (PDF -958KB)Clinical pharmacology (PDF -2.2MB)Statistical (PDF -422KB)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
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
Iohexol - OraltagInterpharma Praha, a.s.Medical (PDF -91KB)Clinical pharmacology (PDF -294KB)Statistical (PDF -98KB)PREA
Iron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -114KB)Statistical (PDF -376KB)PREA
Lamivudine - EpivirViiV Healthcare CompanyMedical (PDF -4.2MB)Clinical pharmacology (PDF -3MB)Statistical (PDF -4.7MB)PREA
Lamivudine and Raltegravir - DutrebisMerck Sharp & Dohme Corp.Medical (PDF -1MB)Clinical pharmacology (PDF -6.4MB)NonePREA
Lamotrigine - Lamictal GlaxoSmithKline LLCMedical (PDF -18MB)Clinical pharmacology (PDF -793KB)Statistical (PDF -1.8MB)PREA
Levalbuterol hydrochloride - XopenexOak PharmaceuticalsMedical (PDF -8.3MB)Clinical pharmacology (PDF -3.9MB)Statistical (PDF -2MB)PREA
Levalbuterol tartrate - Xopenex HFASunovion Pharmaceuticals Inc.Medical (PDF -3.9MB)Clinical pharmacology (PDF -1.2MB)Statistical (PDF 1.3MB)PREA
Levetiracetam - Keppra Extended Release TabletsUCB, Inc.DD Summary Review (PDF -202KB)
CDTL Review (PDF -371KB)
Medical (PDF -327KB)
Clinical pharmacology (PDF -1.2MB)NonePREA
Levonorgestrel - LilettaMedicines360Medical (PDF -8.8MB)Clinical pharmacology (PDF -1MB)
Clinical pharmacology (PDF -2.4MB)
Statistical (PDF -1.5MB)PREA
Levonorgestrel/ethinyl estradiol and ethinyl estradiol - QuartetteTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF -6MB)Clinical pharmacology (PDF -4MB) )
Clinpharm addendum (PDF - 89KB)
Statistical (PDF -1MB)PREA
Levonorgestrel-releasing intrauterine system - SkylaBayer HealthCare Pharmaceuticals, Inc.Medical (PDF - 8MB)Clinical pharmacology (PDF - 4MB)Statistical (PDF - 424KB)PREA
Lisdexamfetamine mesylate - VyvanseShireMedical (PDF - 2.4MB)NoneStatistical (PDF - 1MB)PREA
Lopinavir / Ritonavir - Kaletra New!AbbVie Inc.Medical (PDF -5.8MB)Clinical pharmacology (PDF -2.3MB)Statistical (PDF -1.9MB)PREA
Memantine hydrochloride - XR CapsulesForest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.)Medical (PDF -2.1MB)Clinical pharmacology (PDF -956KB)Statistical (PDF -1.1MB)BPCA
Mesalamine - Asacol HDWarner ChilcottMedical (PDF -6MB)Clinical pharmacology (PDF -3.2MB)
Clinical pharmacology (PDF - 518KB)
Statistical (PDF -499KB)PREA
Mesalamine - DelzicolWarner Chilcott LLCMedical (PDF -2.8MB)
Medical Addendum (PDF - 495KB)
Clinical pharmacology (PDF -116KB)NonePREA
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 XRRhodes Pharmaceuticals L.P.Medical (PDF -2.3MB)Clinical pharmacology (PDF -3.6MB)Statistical (PDF -1.1MB)
Statistical (PDF -629KB)
Methylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical (PDF -26KB)Clinical pharmacology (PDF -588KB)Statistical (PDF -380KB)PREA
Micafungin sodium - MycamineAstellas Pharma US, Inc.Medical (PDF -6.8MB)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
Naftifine HCL - NaftinMerz Pharmaceuticals, LLCMedical (PDF -488KB)Clinical pharmacology (PDF -1.6MB)Statistical (PDF -188K)PREA
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
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
Oxcarbazepine - Oxtellar XRSupernus Pharmaceuticals, Inc.Medical (PDF -5MB)Clinical pharmacology (PDF -7MB)Statistical (PDF -482KB)PREA
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 - ZenpepAptalis Pharma Limited.Medical (PDF -587KB)NoneNonePREA
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
Phenylephrine hydrochloride ophthalmic solutionParagon BioTeck, IncMedical (PDF -1.4MB)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
Quetiapine fumarate - Seroquel and Seroquel XRAstraZeneca 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 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
Rifapentin - PriftinSanofi US Services Inc.Medical (PDF -10.1MB)Clinical pharmacology (PDF -5.1MB)Statistical (PDF -3.1MB)PREA
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, Incorporated 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)
Sildenafil - RevatioPfizer, Inc.Medical (PDF -6MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -508KB)BOTH
Spinosad - NatrobaParaPRO, LLCMedical (PDF -854KB)Clinical pharmacology (PDF -171KB)NonePREA
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
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, IncorporatedMedical (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  New!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)


Page Last Updated: 07/31/2015
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